Biotech / Finance

FDA Clears Massachusetts Biotech Tesaro's Ovarian Cancer PARP Inhibitor

Mar 27 5:38pm BioSpace.com Featured News
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Tesaro Announces Expanded Development Program For Cancer Drug Niraparib, Stock Spikes Higher

Mar 27 4:32pm FDA
TESARO Inc (NASDAQ: TSRO) shares opened 3.25 percent higher after being halted around 3:30 p.m. ET. The company announced FDA approval of niraparib and plans to initiate registration processes for expanded indications of metastatic ovarian, breast and lung cancers. As of yet, niraparib supports patients with recurrent ovarian, fallopian and peritoneal cancers and is the only PARP inhibitor approved for such treatments in the U.S. “We plan to expand our first-line ovarian cancer strategy to include a combination study that assesses the potential benefit ...Full story available on Benzinga.com...
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It's High Time For Zynerba Positives: Investors Await 3 Key Mid-Stage Trial Reads On Cannabidiol ZYN002

Mar 27 4:07pm FDA
Zynerba Pharmaceuticals Inc (NASDAQ: ZYNE) is about to embark upon a journey with unknown destinations, as investors brace for a trio of reads from the company in the third quarter of 2017. Focus: 3 Phase 2 Reads Of ZYN002 Cantor Fitzgerald said in a note released Monday it remains focused on three key mid-stage trial results of Zynerba Pharma's ZYN002, testing it for adult epilepsy, pain due to osteoarthritis, or OA, and fragile X syndrome, or FXS. ZYN002 is a synthetic cannabidiol, or CBD, formulated as a permeation-enhanced gel for transdermal delivery. CBD is one of the many active cannabinoids identified in cannabis. Following the company's fourth-quarter earnings call, analyst Elemer Piros said he is encouraged by the results of separate clinical studies using CBD in the treatment of epilepsy. This, according to the analyst, supports the potential for a positive readout with ...Full story available on Benzinga.com...
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Trump spokesman: 'We're not saying it's the end of' Obamacare replacement effort

Mar 27 2:54pm Health Care
Republicans last week cancelled a planned vote on an Obamacare replacement plan.
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Exclusive: Novan CEO Talks Strategic Partnerships, 2017 Pipeline, Finance Evaluation

Mar 27 2:29pm Biotech
2016 was a tumultuous year for biotech firms, but Novan Inc (NASDAQ: NOVN), which went public Sept. 21, thrived through the end of its lockup period on March 20. “In the past year, we were able to complete the IPO in extremely challenging market conditions and meaningfully increased our drug development infrastructure,” Novan CEO Nathan Stasko said. “We have a number of development objectives that we advanced during that calendar year.” The company reported about $34.6 million in cash and cash equivalents by the end of 2016. The pharmaceutical industry anticipates continued shakeups in the coming year considering volatile economic and political sentiments, but those conditions aren’t of importance to Stasko, who said he’s focusing on nothing but Novan business. Seeking A Match Novan has garnered increased partner interest through its positive data reports for SB206 trials, and in January, it signed a $10.8-million licensing deal with Sato Pharmaceutical Co. to market the acne-treating SB204 in Japan. Still, it’s seeking additional partners with which it can advance its ...Full story available on Benzinga.com...
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Scientists grew beating human heart tissue on spinach leaves

Mar 27 1:47pm Health Care
An experiment may solve a serious limitation facing lab-grown human tissue transplants.
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7 ways the Trump administration could make Obamacare 'explode'

Mar 27 1:07pm Health Care
Despite ACHA's failure, Trump has signaled that he does not plan to defend Obamacare or its provisions, NBC reports.
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HTG Molecular Rally Runs Out Of Steam

Mar 27 12:12pm Biotech
HTG Molecular Diagnostics Inc (NASDAQ: HTGM) shares appear to have finally run out of steam on Monday after the stock went on an incredible run to close out last week. Following the close on March 22, HTG announced it had received CE marking in the European Union for its HTG EdgeSeq ALKPlus Assay EU.The assay is used to identify lung cancer patients eligible for treatment with ALK-targeted therapeutics. CEO T.J. Johnson said in a press release that the company plans ...Full story available on Benzinga.com...
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Is the White House blaming Paul Ryan for the failed health-care bill?

Mar 27 11:25am Health Care
The blame game is starting, and Fox News host Jeanine Pirro is helping brew contempt for the House Speaker, Vox reports.
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Allscripts Has 20% Upside: Deutsche Bank Upgrades Stock To Buy

Mar 27 10:32am Biotech
Allscripts Healthcare Solutions Inc (NASDAQ: MDRX) announced its targets for 2018–2020, with revenue growth guided to 6–8 percent and EPS growth of 12–15 percent. Both targets were ahead of the estimates but mostly in line with the consensus. Deutsche Bank’s George Hill upgraded the rating on the company from Hold to Buy, while raising the price target from $12.50 to $14.00. Growth Expectations “Allscripts is beginning to show better results as non-recurring revenue has stabilized, recurring revenue grows faster, and the mix continues to shift to recurring revenue, with non EMR (electronic medical record) solutions seeing faster growth,” the analyst mentioned. “The investor day highlighted solutions ...Full story available on Benzinga.com...
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Stories warning of dehydration dangers dont hold water

Mar 27 9:49am Health News Review
Human beings are naturally equipped with a system to regulate fluid intake. It’s thirst, and it works pretty well for the vast majority of us. Still, some news organizations are oddly compelled to remind us to drink more water. In the process, they often propagate ideas that aren’t supported by data. Take this recent USA […]...
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The Context Problem Foils Pharma Online Advertising

Mar 27 9:35am Pharma Marketing Blog
Click on image to enlarge.Last week I came across an article about Johnson & Johnson and other pharma companies pulling their ads from Youtube because they appeared adjacent to hate speech, e.g.; an anti-Semitic clip claiming the existence of a “Jewish World Order” (see the back story embedded at the end of this post or click here). In an official statement Johnson & Johnson said it paused all YouTube digital advertising globally “to ensure our product advertising does not appear on channels that promote offensive content. We take this matter very seriously and will continue to take every measure to ensure our brand advertising is consistent with our brand values.” According to a Bloomberg article, "While Google’s tools can be incredibly sophisticated, allowing ads to follow users from site to site, the software hasn’t fully matched the human judgment necessary to protect brands from inadvertently funneling cash to causes their customers would find objectionable. The high number of intermediaries in digital advertising further complicates the problem. So Google’s announced fixes may not completely solve the challenge." This problem, however is NOT limited to Google, YouTube, and Facebook. It's also a problem for pharma digital marketers looking to place ads in major online media channels. A case in point is the Janssen ad embedded in a STATnews story about a immunotherapy "breakthrough" (see image at left).What's the problem with this and can pharma companies do anything to place limits on digital ad placement by taking account of context?Read more »...
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Setting You Up for Success

Mar 27 9:10am Impactiviti blog
It’s safe to say that we all want to be set up (or set ourselves up) for success. The best leaders, I would hope, want to set their people up for success. And the best providers (vendors, consultants, etc.) want to set their clients up for success. Yes, of course, they want to make money, […]...
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Letting Obamacare implode would be a 'catastrophe,' GOP ex-HHS secretary warns Trump and Ryan

Mar 27 8:38am Health Care
President Trump and Republican leaders need to "regroup" quickly, Tommy Thompson tells CNBC.
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Astrazeneca's Immuno-oncology Candidate Shows Promise

Mar 27 8:37am RSS Feed
What is Immuno-oncology: Immuno-oncology is a therapeutic approach that stimulates the body’s immune system to attack tumours. Oncology is undoubtedly one of the most active R&D areas in pharma. The  immunotherapeutic field is in its infancy and contains a variety of areas including immune...
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World Congress Manufacturers 340B Summit

Mar 27 7:30am Drug Channels
World Congress Manufacturers’ 340B SummitMay 16-17, 2017 | PhiladelphiaJoin pharmaceutical manufacturers, thought leaders, and leading regulatory strategists at the World Congress Manufacturers’ 340B Summit, May 16-17, in Philadelphia. This event will dive deep into the strategic, operational, legal and regulatory implications to pharma manufacturers of the evolving health care landscape around 340B.Through high-level discussion:Create strategies for managing pricing calculations and average ceiling pricesOvercome operational challenges to better align refund strategiesImprove self-disclosure reporting while building better relationships with covered entityGain legal insights and considerations around 340B to better prepare for the changing landscapeReview trends, findings and preparation strategies for increased HRSA auditsConfirmed speakers include executives from Pfizer, J&J, BMS, Fresenius Medical Care, Hogan Lovells, King & Spalding, Sidley, State of Oregon, University of Chicago, NACDS.To learn more or register for this event, visit here. Rates start at $995 for pharmaceutical manufacturers. Drug Channels readers can use discount code DC200 to save $200!This event, co-located with the 2nd Annual Covered Entities’ 340B Summit, provides comprehensive coverage of the 340B program. CPE Credits and CLE Credits* are available.*CLE Pending approvalThe content of Sponsored Posts does not necessarily reflect the views of Pembroke Consulting, Inc., Drug Channels, or any of its employees.Copyright © 2006-2017 Pembroke Consulting, Inc. and Copyright © 2006-2017 Drug Channels. This Feed is for personal non-commercial use only.         ...
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ProQR Appoints David M. Rodman, MD as Chief Development Strategy Officer

Mar 27 7:00am Biotech
LEIDEN, the Netherlands, March 27, 2017 (GLOBE NEWSWIRE) -- ProQR Therapeutics N.V. (NASDAQ:PRQR) today announced that it appointed David M. Rodman, MD as Chief Development Strategy Officer. Dr. Rodman has had a long career in drug development including leadership roles in translational medicine, rare disease drug development, and RNA therapeutics. Dr. Rodman's experience includes a leadership role in developing two approved medicines for cystic fibrosis (CF) at Vertex Pharmaceuticals, as vice president and head of respiratory drug development. He was also the head of translational medicine at Novartis Institute for Biomedical Research. More recently, he was the Chief Medical Officer at MiRagen and Nivalis. Expansion of the ProQR management team will allow the company to unlock the potential of RNA therapeutics as well as expand business capabilities needed to advance the development of our product candidates that now include three programs: QR-010 for CF, QR-110 for Leber's congenital amaurosis Type 10, and QR-313 for dystrophic epidermolysis bullosa.  At ProQR we are just beginning to capitalize on the power of RNA based therapeutics. We believe RNA therapeutics offers a powerful therapeutic approach to severe genetic disease. We believe the RNA approach has advantages over other approaches, and we are excited to fully explore the possibilities for patients. By adding Dave to our leadership, we will be able to strengthen our portfolio and strategically build our pipeline of RNA approaches to treating disease. said Noreen R. Henig, MD, Chief Medical Officer. There are very few opportunities like ProQR where a great team, cutting edge science and the passion for patients come together said David M. Rodman, MD, In joining ProQR I look forward to continue to make an effort for CF patients, but also on making a big impact for patients suffering from other rare diseases. In ...Full story available on Benzinga.com...
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Kraig Biocraft Laboratories Awarded Investment Certificate in Vietnam

Mar 27 6:05am Biotech
ANN ARBOR, Mich., March 27, 2017 (GLOBE NEWSWIRE) -- Kraig Biocraft Laboratories, Inc. (OTCQB:KBLB) ( Company ), the leading developer of spider silk based fibers, announced today that it has just been awarded an Investment Certificate for the production of high technology silk in Vietnam's Quang Nam province. Kim Thompson receives Investment Certificate at Quang Nam Vietnam Investment Conference. Kim Thompson with Vietnam Investment Certificate for Kraig Labs Kraig Labs CEO, Kim Thompson and COO, Jon Rice with the Company's recently awarded Vietnam Investment Certificate Photos accompanying this announcement are available at...
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Ignyta to explore strategic options for cancer candidate taladegib

Mar 27 5:34am PBR - News
Ignyta is exploring strategic options for taladegib and has entered into an amended and restated license, development and commercialization agreement with Eli Lilly and Company for the taladegib oncology program.
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PureTech signs licensing and equity deal with Novartis to advance clinical stage mTORC1 programs

Mar 27 5:25am PBR - News
PureTech Health has signed a licensing and equity agreement with Novartis to advance two clinical-stage programs targeting the mechanistic target of rapamycin complex 1 (mTORC1) pathway.
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Xenons acne drug XEN801 fails in phase 2 trial

Mar 27 5:14am PBR - News
A phase 2 trial of Xenon Pharmaceuticals’ acne drug XEN801 has failed to meet its efficacy endpoints in patients having moderate to severe acne.
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Virtual liver model could reduce number of animal experiments

Mar 27 3:40am Nanowerk Biotech News
Researchers establish a model that simulates biliary fluid dynamics in the liver and predicts drug-induced liver injuries.            ...
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Bacteria produce polymers and intermediate products

Mar 27 2:30am Nanowerk Biotech News
Biotechnologically produced building blocks for chemistry and biodegradable synthetics.            ...
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Genentech's Rituxan gets FDA breakthrough therapy status to treat pemphigus vulgaris

Mar 27 2:18am PBR - News
Roche’s subsidiary Genentech has secured breakthrough therapy status from the US Food and Drug Administration (FDA) for its Rituxan (rituximab) to treat pemphigus vulgaris.
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XENE Loses Face As Acne Trial Flops, NBRV Awaits LEAP Data, Opdivo Scores A Nod

Mar 26 11:03pm RTT - Biotech
Shares of Xenon Pharmaceuticals Inc. (XENE) plunged more than 50\% on Friday as its investigational drug XEN801 failed to meet efficacy endpoints in a phase II trial in patients with moderate to severe acne.
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Crowd-sourced Journal Watch (March 2017)

Mar 26 8:11pm
Catch up on some new and noteworthy publications that drove the conversation this month. As always, crowd-sourced from the best of the biotech Twitter-verse.$ABBV $AGN $AMGN $AXSM $AZN $CERC $CLVS $CRSP $EDIT $ESPR $INCY $JNJ $MDCO $NBIX $NTLA $PFE $REGN $SNY $TSRO $VTGNMust reads: 3 papers on anti-PD1/PDL1 toxicity in @jco\_ascohttps://t.co/ZLzolZIT8Xhttps://t.co/LGsgBL8TXqhttps://t.co/GJMoU4Nwcw— Hal Burstein, MD (@DrHBurstein) March 9, 2017A double whammy Ioannidis research takedown1. statis [...]...
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Filings Reveal Concert Pharma Spurned $250 Million Buyout Offer From Vertex in November 2016

Mar 26 8:00pm BioSpace.com Featured News
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Media Mogul Dumps $125 Million Theranos Stake for $1

Mar 26 8:00pm BioSpace.com Featured News
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Nearly 500 Amgen Staffers to be Reassigned, Relocated or Laid Off in Restructuring

Mar 26 8:00pm BioSpace.com Featured News
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Scientific Breakthrough Could Lead To Development Of Drug That Fights Off Aging And Radiation Damage, Harvard Reveals

Mar 26 8:00pm BioSpace.com Featured News and Stories
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Whats Next After The GOPs Healthcare Implosion?

Mar 25 2:03pm The Medicine Show
Republicans in the House of Representatives withdrew a bill to replace the Affordable Care Act, leaving the law they dubbed ObamaCare in place. What does this failure mean for policy and for the business world? Some thoughts.
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Winners and losers after Friday's pulled health-care bill

Mar 24 5:28pm Health Care
Health-care stocks diverged Friday after the controversial GOP health care bill was pulled from the floor of the House.
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Pelosi calls GOP's health-bill defeat a 'victory for the American people'

Mar 24 5:16pm Health Care
The GOP failed to rally the support needed to pass the bill, facing pressure from both its conservative and moderate wings.
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Trump says Republicans will likely turn to tax reform after Obamacare vote failure

Mar 24 4:36pm Health Care
Republicans will turn their focus to tax reform after getting dealt a blow in their first major policy effort.
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Analyst on the hospital stocks' three-day rally as GOP health-care bill gets postponed

Mar 24 4:33pm Health Care
Hospital stocks continue their three-day rally as the GOP health-care bill got postponed for the second time on Friday.
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Obamacare replacement vote yanked in House as GOP fails to win support

Mar 24 4:23pm Health Care
For the second time, GOP leaders postponed a scheduled vote amid objections from conservatives and moderates.
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Paul Ryan says House will 'proceed' with tax reform despite health-care 'setback'

Mar 24 4:14pm Health Care
"We came really close today, but we came up short," Ryan said.
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What do Trump and Ryan really think about Obamacare?

Mar 24 4:07pm Health Care
Here's a running list of things President Trump and Republican Speaker Paul Ryan have said about Obamacare.
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Simple math shows why passing the health bill was crucial for passing tax reform

Mar 24 3:55pm Health Care
Failing to replace Obamacare creates a budget crunch that could make tax reform a whole lot harder to achieve.
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Watch: House Speaker Paul Ryan talks after GOP yanks Obamacare replacement

Mar 24 3:48pm Health Care
The GOP failed to rally the support needed to pass the bill, facing pressure from both its conservative and moderate wings.
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Do Analysts See A Path Forward For Ophthotech's Fovista?

Mar 24 3:35pm Biotech
After the release of Ophthotech Corp (NASDAQ: OPHT)'s fourth-quarter results, Leerink weighed in on the possibility of a path forward for Fovista, the company's candidate for the treatment of wet age-related macular degeneration. The Disappointment The company announced disappointing results from two Phase 3 studies in December, Leerink analysts Joseph Schwartz and Dae Gon Ha said in a note. The studies compared the effectiveness of the drugs Fovista and Lucentis together vs. Lucentis monotherapy. A recent Ophthotech earnings call provided opportunity for the Leerink analysts to learn more about the strategic review plan the company announced earlier this month. The Way Forward Ophthotech is proceeding with a Phase 3 clinical trial of Fovista, administered in combination with Eylea or Avastin. This route could generate a new ...Full story available on Benzinga.com...
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Setting The Stage For Neurocrine's Pending PDUFA Date, Barclays Remains Positive

Mar 24 3:18pm FDA
Neurocrine Biosciences, Inc. (NASDAQ: NBIX) is on the verge of becoming a commercial biotech company, as its PDUFA date for Ingrezza in tardive dyskynesia (TD) approaches. The FDA is expected to announce a decision in early April. Consequently, Neurocrine’s management team has shifted its focus to the drug’s commercialization and sales potential, Barclays analysts Geoff Meacham, Ph.D., and Paul Choi revealed in a report issued Friday. Given the relevance of Ingrezza in Barclays’ thesis on the company, the analysts decided to reach out to specialist physicians, seeking to arrive at a better assessment of the opportunity the ...Full story available on Benzinga.com...
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Americans ought to be disgusted with Congress, House Democratic Whip says

Mar 24 3:11pm Health Care
House Democratic Whip Steny Hoyer told CNBC on Friday he doesn't blame Americans who may have lost faith in Congress, because he feels their pain.
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Trump has 'left everything on the field' for health-care bill, Spicer says

Mar 24 1:57pm Health Care
The White House spokesman says the House is scheduled to vote on the GOP health bill at 3:30 p.m. ET.
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'Spider-Man' Glenn King Hopes His Potential Stroke-Saving Arachnid Molecule Makes It To Market

Mar 24 1:50pm FDA
The journey is just beginning for Glenn King, a researcher whose team found that the world’s most poisonous spider could provide fast treatment for stroke victims and stop their brain cells from burning out. The initial findings were presented this week in the journal Proceedings of the National Academy of Sciences. Media coverage has been huge in Britain and King’s homeland, Australia, while U.S. attention has been scant. To investors, this is biotech at its most basic; the discovery process, something happening in a distant laboratory. The years-long route from lab rats to FDA drug approval will be painstaking, exacting, and not necessarily successful. “We’ve been down this road dozens and dozens of times,” Dr. Larry Goldstein, professor and chairman of the Department of Neurology at the University of Kentucky and past chair of The Stroke Council of the American Heart Association, told Benzinga. “It is certainly a novel approach and looks interesting,” he said of King’s research. “Whether it pans out is complete conjecture.” A Deadly Creature’s Hidden Gift King, a scientist at the University of Queensland Institute for Molecular Bioscience, experiments with the venom of scorpions, centipedes and spiders to find treatments for a variety of diseases, from chronic pain to erectile dysfunction. His lab is filled with 50 types of venom and the living ...Full story available on Benzinga.com...
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Paul Ryan reportedly tells Trump the GOP lacks votes to pass Obamacare replacement

Mar 24 1:41pm Health Care
Republicans are trying to rally support for their Obamacare replacement bill ahead of a House vote.
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Trump shrugs, says 'we'll have to see' when asked what happens if his Obamacare replacement fails

Mar 24 11:58am Health Care
Trump's American Health Care Act faces opposition from conservative and moderate members of the Republican caucus.
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How The American Health Care Act Could Affect Digital Health

Mar 24 10:55am Science Business
Although the future is uncertain, it's clear that industry experts all agree on one thing: digital innovation in healthcare will have an even greater impact in light of the changes ahead.
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Here Are The 4 Commercial Launches In 2017 That Earned Tesaro A Buy Rating At Argus

Mar 24 10:49am Biotech
TESARO Inc (NASDAQ: TSRO) has strong prospects in immuno-oncology, as it prepares for four commercial launches in 2017 and plans to initiate pivotal studies for several products, Argus’s Stephen Biggar said in a report. He initiated coverage of the company with a Buy rating and a price target of $210. Tesaro reported a net loss for fourth-quarter 2016 of $2.60 per share, versus $1.89 in Q4 of 2015. Revenue came in at $4.2 million, compared to $0.2 million in Q4 2015. Product Pipeline Tesaro has planned new product launches in the US and Europe. “We expect continued ...Full story available on Benzinga.com...
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Freedom Caucus holdout blasts Obamacare replacement bill as largest welfare program in GOP history

Mar 24 9:59am Health Care
Rep. Mo Brooks tells CNBC the House Obamacare replacement plan is the worst bill he's seen in 30 years of public service.
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Not statistically significant but clinically meaningful: A researcher calls BS on cancer drug spin

Mar 24 9:49am Health News Review
An egregious example of pharma spin was highlighted by Dr. Vinay Prasad, an oncologist at Oregon Health Sciences University, this week on Twitter. He pointed to a Novartis promotional website for the immunosuppressant drug everolimus (brand name Afinitor) that’s used to treat kidney and other cancers. His annotation of a graphic on the site called […]...
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Judge dismisses two Express Scripts claims in Anthem drug pricing lawsuit

Mar 24 9:27am Health Care
Judge Edgardo Ramos in Manhattan dismissed Express Scripts' claim that Anthem breached an implied covenant of good faith and fair dealing.
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Trump presses Freedom Caucus on health care: A no vote helps Planned Parenthood

Mar 24 9:17am Health Care
Trump warns the Freedom Caucus that federal funding will still go to Planned Parenthood if the status quo is maintained.
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Believe Trump pass GOP health bill or Obamacare stays, warns White House budget director Mulvaney

Mar 24 9:05am Health Care
White House budget director Mick Mulvaney also tells CNBC he's not sure the administration has enough votes for passage.
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These are the lawmakers deciding on maternity coverage repeal

Mar 24 8:26am Health Care
You may notice a certain group of people missing from decisions on AHCA's repeal of "essential benefits," Vox reports.
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Freedom Caucus member: Obamacare replacement bill is largest welfare program in GOP history

Mar 24 8:25am Health Care
Rep. Mo Brooks tells CNBC the House Obamacare replacement plan is the worst bill he's seen in 30 years of public service.
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European Medicines Agencys CHMP Recommends Approval of Mercks KEYTRUDA (pembrolizumab) for the Treatment of Patients with Relapsed or Refractory Classical Hodgkin Lymphoma

Mar 24 8:13am Prescription Medicine News
Dateline City: KENILWORTH, N.J. Recommendation Is for Adult Patients Who Have Failed Autologous Stem Cell Transplant and Brentuximab Vedotin (BV), or Who Are Transplant-Ineligible and Have Failed BV KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) and brentuximab vedotin (BV), or who are transplant-ineligib Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558Kim Hamilton, 908-740-1863orInvestors:Teri Loxam, 908-740-1986Amy Klug, 908-740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE @Merck read more...
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Don't expect a Seinfeld yada-yada-it-becomes-law scenario if GOP health bill advances, AEI warns

Mar 24 8:04am Health Care
The imperiled GOP Obamacare replacement bill would still face a difficult road to becoming law, an AEI analyst says.
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