Biotech / Finance

The Hard Stuff: Postnatal Depression

May 28 8:26pm Pregnancy Exercise
Last night was our final anti-natal class.  What started 6 weeks ago as fun toy baby bathing activities, drawing diagrams of the female anatomy, and having our partners learn try-at-home massage techniques, has ended in a very serious topic… Post Natal Depression (PND).  It’s a topic, that although made the room a bit subdued, I […]...
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How Much The Opioid Epidemic Actually Costs The Non-User

May 28 3:15pm Biotech
It’s easy for the average American to dismiss the impact of the nation’s opioid abuse epidemic. However, heroin and prescription opioid painkiller addiction may be costing Americans much more than they realize. A recent study by the U.S. Surgeon General found that 27 million Americans reported misusing illegal drugs or opioid-based prescription painkillers last year. The same study estimates that the nation is spending a total of $442 billion annually dealing with the fallout from drug and alcohol abuse. Epidemic Costs Non-Users, Too A 2015 report by Matrix Global Advisors estimated that prescription painkiller abuse alone results in at least $25 billion in annual healthcare costs and $55 billion in total annual costs to society. Matrix estimated that the state of California incurs the largest opioid ...Full story available on Benzinga.com...
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Friday Night News Dump (Memorial Day edition)

May 28 2:06pm
A round-up of all the biotech news dumped Friday night while you were heading off for Memorial Day weekend festivities!$SGMO $200M mixed shelf https://t.co/Dm3RBSa8Fz— Odi Bruckman (@odibro) May 26, 2017$TGTX $300M ATM with 7 banks. That has to be a record.— Adam Feuerstein (@adamfeuerstein) May 26, 2017$IPCI $100m mixed shelf— Shane Blackmon (@shaneblackmon) May 26, 2017$SGMO $75m ATM offering through Cowen— Shane Blackmon (@shaneblackmon) May 26, 2017$CYCC $15M offering— Odi Bruckman [...]...
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TC Heartland Supreme Court Limits Venue in Patent Suits

May 27 8:15pm Biotechnology Patent Law Blog | Patents4Life by Warren Woessner
Monday, in a unanimous opinion (Goresuch did not participate), the Supreme Court interpreted the patent venue statute (28 USC s. 1400(b)) to require that the phrase “where the defendant resides” be limited to the defendant’s state of incorporation, not to … Continue reading → The post “TC Heartland” Supreme Court Limits Venue in Patent Suits appeared first on Patents4Life | Warren Woessner.
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FDA Has Many Hurdles to Overcome in its Effort to Stem the Current Opioid Addiction Epidemic it Helped to Create

May 27 9:51am Pharma Marketing Blog
The FDA has made many efforts to deal with the current opioid addiction crisis. The latest is the establishment of a "Opioid Policy Steering Committee." Some of these efforts may have been compromised by the influence of patient advocacy groups sponsored by drug companies that produce and market opioids. Such groups have gotten a seat on FDA panels. So, one has to wonder who will be named to the new steering committee.Listen to podcast below: Read the transcript, which includes links to more information, below.Read more »...
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The GOP's health-care bill is a polling disaster, with voters apt to punish senators who support it

May 26 2:17pm Health Care
The polls follow a Congressional Budget Office estimate that the bill will lead to 23 million more uninsured people.
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Week 36: Its the final countdown

May 26 10:08am Knocked Up – Pregnancy & Newborn Magazine
36 weeks, people! I had an appointment with my OB on Wednesday to check on my cervix and the baby’s position; I’ll be going in weekly now to keep tabs. As extremely embarrassing as pelvic exams always are, I did … Continue reading → The post Week 36: It’s the final countdown appeared first on Pregnancy & Newborn Magazine.
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We are in a crisis of crap health news this weeks reporting shows why

May 26 7:02am Health News Review
I can’t remember a week that has featured so much useless reporting about studies that are meaningless to the average reader. All the stories featured clickbait-y diet topics like alcohol, chocolate, coffee, and fiber. All were based on observational studies that can only show associations, not cause-and-effect, and which are prone to drawing conclusions that […]...
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Assembly Biosciences Announces June Conference Presentations

May 26 7:00am Biotech
INDIANAPOLIS, May 26, 2017 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (NASDAQ:ASMB), a clinical-stage biotechnology company advancing a new class of oral therapeutics for the treatment of hepatitis B virus (HBV) infection and novel oral live biotherapeutics for disorders associated with the microbiome, today announced presentations at two upcoming conferences: •  Jefferies 2017 Global Healthcare Conference – New YorkDate/Time: Wednesday, June 7, 2017 at 10:00 am ETPresenter: Derek Small, Chief Executive Officer *A webcast of the corporate presentation will be available in the Investor Relations section of the Company's website at www.assemblybio.com •  Microbiome Drug Development Summit – BostonDate/Time: Wednesday, June 28, 2017 at 5:15 pm ETPresenter: Miguel Barbosa, PhD, Chief Scientific Officer, Microbiome Program Separately, the company announced grants of options to purchase 89,750 shares of Assembly's common stock with an exercise price of $25.40 per share, the closing price on May 25, 2017, to ten new non-executive employees. The stock options have a ten-year term and vest over four years, with one-fourth vesting on the first anniversary of the date of grant and the remaining three-fourths vesting in equal ...Full story available on Benzinga.com...
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Merck licenses Teijin Pharma's Alzheimer's candidate

May 26 4:46am PBR - News
Merck has signed a worldwide license agreement with Teijin Pharma for the development, manufacture and commercialization of an investigational preclinical antibody candidate targeting the protein tau.
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Harpoon Therapeutics raises $45m in new funding round

May 26 4:44am PBR - News
Harpoon Therapeutics has secured $45m in Series B financing, which included new investors Arix Bioscience, New Leaf Venture Partners and Taiho Ventures along with existing investor MPM Capital.
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Designer viruses stimulate the immune system to fight cancer

May 26 4:09am Nanowerk Biotech News
Scientists have created artificial viruses that can be used to target cancer. These designer viruses alert the immune system and cause it to send killer cells to help fight the tumor. The results provide a basis for innovative cancer treatments.            ...
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Company Spotlight: BioCryst Pharmaceuticals

May 26 2:33am RTT - Biotech
Shares of BioCryst Pharmaceuticals Inc. (BCRX) are up nearly 15\% over the last 5 trading days.
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FDA panel recommends Pfizers epoetin alfa biosimilar to treat anemia

May 26 2:14am PBR - News
The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) has recommended the approval of Pfizer's biosimilar to Amgen’s anemia drug Epogen (epoetin alfa) across all indications.
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Gainers & Losers Of May 25: AERI, BCRX, NEOT, SNDX, SYRS...

May 25 8:43pm RTT - Biotech
Do you have AERI, BCRX and NEOT in your portfolio?...
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Can MEI Pharma Rise Nearly 300%?

May 25 8:00pm BioSpace.com Featured News and Stories
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Spark Therapeutics: The Next Big Thing In Gene Therapy?

May 25 8:00pm BioSpace.com Featured News and Stories
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Has Aerie Pharma Put The 'Binary Boogeyman' To Bed With Roclatan Phase 3 Data?

May 25 2:24pm FDA
Aerie Pharmaceuticals Inc (NASDAQ: AERI) shares were seen up over 29 percent Thursday after the company reported positive Phase III trial data on its glaucoma treatment candidate, Roclatan. According to the company, Roclatan achieved the primary efficacy endpoint in demonstrating superiority over both latanoprost and Rhopressa. Investors cheered the positive news, but Aerie may have even more upside in the months ahead, H.C. Wainwright analyst Corey Davis said. “Amidst reporting broad success in its Phase 3 MERCURY 2 trial of Roclatan vs. its Rhopressa and latanoprost subcomponents at all 9 observed timepoints, responder analysis indicating 32 percent of patients reached IOPs below 14 mmHg by ...Full story available on Benzinga.com...
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Big Obamacare insurer wants steep rate hike but would have taken less if Trump, GOP funded payments

May 25 2:03pm Health Care
Blue Cross and Blue Shield NC says it would have asked for just an 8.8 percent increase, and not almost 24 percent.
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UnitedHealth and Merck strike a deal to explore linking payments to drug performance

May 25 2:00pm Health Care
UnitedHealth's Optum unit has signed a multiyear agreement with Merck to develop a better way to reimburse drugmakers.
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Is The FDA Panel Vote On Puma Biotech Likely To Lead To Actual Approval?

May 25 1:47pm FDA
Shares of Puma Biotechnology Inc (NASDAQ: PBYI) hit a new 52-week high of $80.00 Thursday morning after the company confirmed that the U.S. Food and Drug Administration's Oncologic Drugs Advisory Committee voted 12–4 to recommend approval of PB272 (neratinib) for the treatment of early stage breast cancer. 12–4, But No Definitive Approval ... Yet Following the vote, Credit Suisse's Alethia Young maintained an Outperform rating on Puma's stock with a price target boosted from $58 to $90, although the company's announcement doesn't yet imply the approval of neratinib. The analyst did state that the FDA's vote of 12–4 in favor of ...Full story available on Benzinga.com...
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GOP health-care bill could cost some women $1,000 more per month for 'maternity' insurance coverage

May 25 12:42pm Health Care
The Obamacare replacement bill includes provisions that may allow insurers to eliminate essential health benefits in plans.
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Inovio's HIV Vaccine Elicits High Response Rates In Phase 1 Trial

May 25 12:15pm FDA
Following the results release of an early-stage study of Pennvax-GP, Inovio Pharmaceuticals Inc (NASDAQ: INO)'s HIV vaccine, H.C. Wainwright noted that the vaccine elicited high T-cell and antibody immune responses in healthy and uninfected adults. The Trial Analysts Raghuram Selvaraju and Yi Chen noted that a four-dose regiment of Pennavax-GP DNA vaccine, containing four HIV antigens, was administered at months 0,1,3 and 6 by intradermal or intramuscular administration, in combination with an immune activator, IL-12, dubbed INO-9012. The analysts noted that the goal of development is to attain long-term HIV remission in the absence of antiviral drugs. The study plan, according to the analysts, includes a two-step clinical study in HIV-positive subjects to assess PENNVAX-GP with INO-9012 alone and with the addition of a PD-1 checkpoint inhibitor. The study is designed to test whether enhancing anti-HIV specific CD8 killer T cell immune responses alone or in combination with other products can influence the size of the viral reservoir pool, potentially resulting ...Full story available on Benzinga.com...
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Puma Biotech 'Is The Real Deal,' Overcomes Controversy With Positive FDA Panel Vote

May 25 11:21am FDA
Puma Biotechnology Inc (NASDAQ: PBYI) investors got some major vindication Wednesday when the FDA’s Oncologic Drugs Advisory Committee voted 12–4 to recommend approval of neratinib for treatment of patients with early-stage HER2-positive breast cancer. Puma had plenty of doubters and short sellers out there, which have only fueled the stock’s massive 105-percent gain this week. FDA Approval Almost Here FDA approval for neratinib is all but certain at this point, Citi analyst Yigal Nochomovitz said. FDA oncology chief Richard Pazdur has been mostly quiet on neratinib, which is typically a sign he will not fight approval. Despite concerns over patient diarrhea, filing delays and modifications to trial ...Full story available on Benzinga.com...
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Laughing Gas During Labor: Is Nitrous Oxide Safe?

May 25 11:18am Pregnancy – Mama Natural
Nitrous oxide, a.k.a. laughing gas has been used as a form of pain relief since the late 1900’s, although you’re more likely to see it at the dentist’s office than a birth center. Epidurals are the pain relief of choice in the U.S. but that may be changing. Laughing gas has been widely available for […] The post Laughing Gas During Labor: Is Nitrous Oxide Safe? appeared first on Mama Natural.
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Corium Hopes Stock Offering Will Firm Its Footing In Pharma Partner Talks

May 25 11:16am Biotech
Wall Street wasn't too thrilled by Corium International Inc (NASDAQ: CORI)'s common stock offering. Corium offered 5.6 million shares priced at $6.25 per share and expected gross proceeds of about $35 million. Also revealed Thursday morning, Perceptive Advisors purchased nearly 2 million Corium shares at $6.25 per share. Shares plummeted more than 8 percent as investors may have interpreted the move as refutation of Corium’s previous pursuit of partnerships. CEO Peter Staple previously said he preferred to finance the biopharmaceutical's upcoming Corplex pivotal study through partnerships ...Full story available on Benzinga.com...
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The Montana special election 'bodyslam' story has an important point about the GOP health-care bill

May 25 10:30am Health Care
The stakes are high around health care for Republicans in vulnerable districts, Vox reports.
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The anatomy of a drug website: 5 pharma tactics to be wary of

May 25 9:59am Health News Review
Imagine you have an amazing office visit with Dr. Wunderbar who offers the following:  unequivocal confirmation that the symptoms you’ve been experiencing actually represent an accepted disease with a real name  studies, statistics, and even anecdotes from other patients validating your experience  help in finding discounted prices for the proven treatments you’ll need enough time to answer […]...
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For insurers, CBO sees more flexibility and instability in GOP's revised health-care bill

May 25 9:06am Health Care
For health insurers, the Congressional Budget Office's report on the House's revised American Health Care Act presents a mixed bag.
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Obamacare replacement could make costs soar for many sick and older people

May 25 8:42am Health Care
Sick Americans and older people could see costs spike under the House-passed Obamacare replacement plan.
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Abeona Therapeutics Receives FDA Orphan Drug Designation for EB-101 Gene Therapy Product for Patients with Epidermolysis Bullosa

May 25 8:05am Biotech
Abeona's Third Gene Therapy Program to Receive FDA Orphan Designation EB-101 Gene Therapy for Recessive Dystrophic Epidermolysis Bullosa (RDEB) has Demonstrated Promising Efficacy and Safety in Ongoing Phase 1/2 Clinical Trial NEW YORK and CLEVELAND, May 25, 2017 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO), a leading clinical-stage biopharmaceutical company focused on developing novel gene therapies for life-threatening rare diseases, announced today that the FDA has granted Orphan Drug Designation (ODD) for Abeona's EB-101 gene therapy program for patients with dystrophic epidermolysis bullosa (DEB), including recessive dystrophic epidermolysis  bullosa (RDEB), which are life-threatening genetic skin disorders characterized by skin blisters and erosions that cover the body. Abeona is committed to advancing innovative gene therapies that address the unmet needs of patients suffering with dystrophic epidermolysis bullosa, a devastating rare skin disease.  We are grateful that the FDA has recognized EB-101 as a rare disease product that may offer a significant therapeutic benefit for patients with dystrophic forms of epidermolysis bullosa, including RDEB.  EB-101 is Abeona's third gene therapy program to be granted Orphan Drug Designation by the FDA, an important value driver for the program as it provides seven years of market exclusivity from similar medicines for similar indications, stated Timothy J. Miller, Ph.D., President & CEO of Abeona Therapeutics Inc. Typically, wounds on patients with RDEB, also known as "butterfly skin" syndrome, can remain unhealed for months to years due to the inability of the skin to stay attached to the underlying dermis and can cover a large percentage of the body.  In the Phase 1/2 clinical trial, EB-101 was administered to non-healing chronic wounds on each subject and assessed for wound healing at predefined time points over years. The primary endpoints of the clinical trial assess safety and evaluate wound healing after EB-101 administration compared to control untreated wounds. Secondary endpoints include expression of collagen C7 and restoration of anchoring fibrils at three and six months post-administration. Clinical data were recently presented at the Society of Investigative Dermatology (SID) conference by Stanford collaborators, and demonstrated that EB-101 treat...
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BioCryst Reports Additional Positive Results From the Second Interim Analysis of Its APeX-1 Trial

May 25 8:00am Biotech
RESEARCH TRIANGLE PARK, N.C., May 25, 2017 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced results from a second interim analysis of its Phase 2 APeX-1 clinical trial in hereditary angioedema (HAE). APeX-1 is a 3-part dose ranging trial designed to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered once-daily (QD) BCX7353 for 28 days, as a preventative treatment to reduce the frequency of attacks in HAE patients. This second interim analysis evaluated data from all patients in Parts 1 and 2 of the trial. The first interim analysis evaluated data from 28 of 36 patients in Part 1. These data support our hypothesis regarding the initial findings seen from the first interim analysis, said Jon Stonehouse, Chief Executive Officer & President of BioCryst. "We are delighted to see that a daily dose of 125 mg of BCX7353 results in a high level of efficacy with an improved tolerability profile compared to the 350 mg dose observed in the first interim analysis. We look forward to completing Part 3 of the trial to select appropriate doses for our pivotal program. This second interim analysis of pooled data from Parts 1 and 2 evaluated doses of BCX7353 125 mg (n=7), 250 mg (n=6) and 350 mg (n=18) QD versus placebo (n=20) for 28 days. The baseline attack rate was approximately 1/week. Baseline characteristics were generally well balanced between the treatment groups. Compliance with study drug dosing was excellent (≥ 98\%). The pre-specified per-protocol (PP) interim analysis included data on a total of 44 subjects with confirmed Type 1 or Type 2 HAE completing 28 days of treatment. The percentage reductions by treatment group in the mean rate of independently-adjudicated angioedema attacks for the pre-defined effective dosing period (weeks 2 through 4) in BCX7353 treated subjects were: 125 mg QD, 73\% (p=0.002); 250 mg QD, 37\% (p=0.128) and 350 mg QD, 58\% (p=0.001) compared to placebo. In the intent-to-treat (ITT) population, corresponding reductions by treatment group were: 125 mg QD, 73\% (p=0.004); 250 mg QD, 44\% (p=0.090) and 350 mg QD, 45\% (p=0.014) compared to placebo. A pre-planned analysis of peripheral and abdominal attacks showed reductions in peripheral attacks of 74\% (125 mg QD), 54\% (250 mg QD) and 90\% (350 mg QD) compared with placebo...
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Scientists borrow from electronics to build circuits in living cells

May 25 5:51am Nanowerk Biotech News
A team of synthetic biology researchers have demonstrated a new method for digital information processing in living cells, analogous to the logic gates used in electric circuits.            ...
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Biotech Stocks Facing FDA Decision In June

May 25 5:32am RTT - Biotech
June is certainly going to be busy month for the FDA, with over 10 drug candidates looking forward to knowing their fate. Let's take a look at some of the biotech stocks awaiting FDA decision in June.
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Neurocrines Ingrezza fails in phase II Tourette syndrome study

May 25 5:13am PBR - News
Neurocrine Biosciences said that the initial phase II Tourette syndrome T-Force GREEN study of INGREZZA (valbenazine), a small molecule VMAT2 inhibitor, did not meet its primary endpoint.
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Debiopharm acquires ImmunoGens ADC IMGN529/Debio 1562

May 25 5:05am PBR - News
Debiopharm International has acquired ImmunoGen's IMGN529/Debio 1562, a clinical-stage anti-CD37 ADC for the treatment of patients with B-cell malignancies, such as non-Hodgkin lymphomas (NHL).
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Inovios HIV vaccine succeeds in early stage trial

May 25 3:59am PBR - News
Inovio Pharmaceuticals' Pennvax-GP HIV vaccine has demonstrated nearly 100\% immune response rates in a clinical study.
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Week 18: Its a !

May 25 12:00am Knocked Up – Pregnancy & Newborn Magazine
Wait, wait, wait … You’ll have to read a bit of my blathering before you get to the good stuff! I had an appointment at the birthing center with our midwife on Monday, and I got to hear sweet little … Continue reading → The post Week 18: It’s a … ! appeared first on Pregnancy & Newborn Magazine.
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Gainers & Losers Of May 24: PBYI, INO, NVCR, AKAO, NBIX...

May 24 9:53pm RTT - Biotech
Do you know why PBYI, INO and SBPH soared?...
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3 Healthcare Stocks For Savvy Investors

May 24 8:00pm BioSpace.com Featured News and Stories
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How To Double Your Money On A 6% Up Move In Gilead

May 24 8:00pm BioSpace.com Featured News and Stories
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Roche's New MS Drug Linked to Deadly Brain Infection

May 24 8:00pm BioSpace.com Featured News
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10 End of Pregnancy Struggles

May 24 7:43pm Pregnancy Exercise
The last few weeks and days of pregnancy are a funny old time. You’re one half desperate to meet your baby and so uncomfortable that the thought of labour is actually quite exciting (or is that just me!?). But then the other half of you is freaking out about coping with a newborn and getting […]...
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Obamacare replacement could make costs soar for many sick people and those over 64

May 24 6:23pm Health Care
Sick Americans and older people could see costs spike under the House-passed Obamacare replacement plan.
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23 million fewer people would have insurance under GOP health-care bill, CBO says

May 24 6:02pm Health Care
The new Congressional Budget Office report also projects how premium prices will change under the bill.
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Weekly dose of chocolate lowers AFib risk? Oh how we wish it were true

May 24 2:28pm Health News Review
Right on the heels of Tuesday’s overblown news that “even one glass of alcohol a day raises your breast cancer risk” comes another series of diet-related headlines–this time on another foodstuff guaranteed to garner publicity: chocolate. In this case, instead of chocolate being bad, we learn it might be good: Researchers reviewing data from the […]...
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Puma Biotech Gets Favorable FDA Vote On Neratinib

May 24 1:36pm FDA
Puma Biotechnology Inc (NASDAQ: PBYI) traders are eagerly-anticipating the end of the trading halt for Puma on Wednesday after the company received a positive recommendation for approval of neratinib from the FDA’s Oncologic Drugs Advisory Committee. The advisory committee voted 12-4 to recommend approval of neratinib for treatment of patients with early-stage HER2-positive breast cancer. The stock is scheduled to resume trading at 1:50 p.m. ET. When the stock resumes trading, it could make a huge jump. Shares spiked 39.1 percent on Monday after the FDA’s initial review of neratinib was let critical ...Full story available on Benzinga.com...
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CBO's report card on Obamacare repeal bill could add more fuel to health-care debate

May 24 12:36pm Health Care
The Congressional Budget Office will estimate how many more people would become uninsured under the Republican plan.
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FDA Panel Votes 12 To 4 to Approve Pumas Breast Cancer Drug

May 24 12:32pm The Medicine Show
A panel of experts convened by the Food and Drug Administration says that a drug for breast cancer developed by Puma Biotechnology should be approved, but argued for more limits on which women should get the medicine.
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US ban for Changzhou Jintan Qianyao raises questions about customers says expert

May 24 11:10am in-PharmaTechnologist RSS
The US FDA has banned APIs made by Changzhou Jintan Qianyao Pharmaceutical Raw Materials after staff told inspectors their quality testing plans were “in their heads.”...
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Q1 Seasonality In The Pharma/Biotech Space: What It Is, Why It Happens And Who Is Affected

May 24 11:02am Biotech
Biotech investors may have noticed that the first quarter of the year is a bit sluggish for drug sales. They aren’t imagining things, according to Bernstein analyst Aaron Gal. Bernstein analyzed a group of about 40 drugs and found that Q1 sales declined by about 7 percent compared to Q4 sales in the past three years. Gal identified four primary drivers of the seasonal slump: 1. Less drugs are utilized in Q1 because of managed care rejections due to patients switching plans or new utilization policies, as well as patients opting not to purchase prescription drugs because their out-of-pocket cost is too high. 2. High deductibles for commercial plans can place a heavy burden on ...Full story available on Benzinga.com...
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BUYING FOR BABY

May 24 10:28am Destination Maternity Blog
Oh baby, baby! What little presents can you get your little present? Going to big, overcrowded stores can be exhausting and overwhelming. That’s why more and more of our customers are loving that we sell baby toys and clothes now too. Our name is Motherhood, so we want to make sure we help you ladies […]...
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Puma Biotechnology FDA Live Blog

May 24 8:12am The Medicine Show
A live blog of the FDA's deliberations on neratinib, a breast cancer drug developed by Puma Biotechnology.
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Granules India confirms $35m US plant expansion will create jobs

May 24 6:01am in-PharmaTechnologist RSS
Granules India says adding manufacturing capacity at its facility in Virginia, US will create 102 jobs.
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FDA approves Mercks Keytruda for cancer patients with certain biomarkers

May 24 5:26am PBR - News
The US Food and Drug Administration (FDA) has granted accelerated approval to Merck’s Keytruda for patients whose cancers have a specific genetic feature (biomarker).
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Eye drops to replace painful injections in AMD patients

May 24 2:31am in-PharmaTechnologist RSS
The University of Birmingham has developed a cell-penetrating peptide it claims could be used to make eye drop versions of age-related macular degeneration drugs currently delivered by injection.
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US FDA rejects Sun epilepsy drug due to ongoing problems at Halol plant

May 24 2:31am in-PharmaTechnologist RSS
The US FDA has refused to reapprove Sun Pharma Advanced Research LTD’s epilepsy drug Elepsia XR (levetiracetam) citing problems at its plant in Halol, India.
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MRK's Keytruda Scores Another FDA Nod, NBIX Disappoints, SBPH Achieves It

May 24 1:25am RTT - Biotech
Today's Daily Dose brings you news about FDA approval of Merck's Keytruda for yet another indication; Neurocrine's disappointing phase II study of Ingrezza in Tourette syndrome; Spring Bank's results from phase 2a segment of its ACHIEVE trial and Syndax' public offering.
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