FiercePharma: Pharma
FDA stiff-arms Sanofi and Lexicon's Type 1 diabetes hopeful Zynquista
Fri, 22 Mar 2019 18:44:07 +0000
When a panel of experts couldn’t agree on the merit of Sanofi and Lexicon’s SGLT1/2 inhibitor Zynquista for Type 1 diabetes, Sanofi stood behind the drug. But now the FDA has handed down its decision against it.
From AbbVie's upadacitinib to new gene therapies: Pharma's 2019 blockbuster launches, ranked
Fri, 22 Mar 2019 15:13:49 +0000
Analysts with Cortellis expect seven blockbuster drug launches in markets across the world this year. AbbVie's upadacitinib leads the pack with expected 2023 sales of $2.2 billion.
Democrats push back at North American trade deal over biologic drug exclusivity
Fri, 22 Mar 2019 13:38:45 +0000
Amid a national conversation over drug prices, Democrats are raising concern with the trade deal negotiated between the U.S., Canada and Mexico.
FiercePharmaAsia—Aducanumab Alzheimer’s flop; Keytruda’s Chinese market; Samsung BioLogics probe
Fri, 22 Mar 2019 09:56:52 +0000
Biogen and Eisai's Alzheimer's candidate aducanumab didn't make it through phase 3 testing; analysts argue Keytruda could see blockbuster sales in China thanks to its stellar clinical profile; South Korean prosecutors raid Korea Exchange offices in Samsung BioLogics probe; and more.
FDA warns doctors, myeloma patients of doubled death risk from AbbVie, Roche's Venclexta
Fri, 22 Mar 2019 06:03:52 +0000
Earlier this month, the FDA halted enrollment in multiple myeloma clinical trials featuring AbbVie and Roche drug Venclexta. Now, it’s officially warning doctors, researchers and patients about the drug—and dishing on the data that prompted the moves.
Could proxy advisers sway investors to vote ‘no’ on BMS-Celgene merger?
Thu, 21 Mar 2019 14:47:18 +0000
Bristol-Myers and the activist investors at Starboard have had their say on the pending $74 billion Celgene merger. Some influential voices—namely proxy advisers—have yet to weigh in, though, and their verdicts could sway undecided shareholders ahead of the crucial April 12 vote.
Where can Biogen turn after mammoth Alzheimer's blow? The M&A table, analysts say
Thu, 21 Mar 2019 14:15:50 +0000
Biogen’s worst fears have come true with the failure of its phase 3 Alzheimer’s prospect aducanumab. And with one of its key blockbusters under threat, it may be “buy or be bought” time for the Big Biotech.
Jazz scores FDA nod for sleepiness drug Sunosi, but a launch will have to wait
Thu, 21 Mar 2019 13:53:50 +0000
It didn’t always look certain, but on Wednesday, Jazz Pharma's Sunosi scored an FDA approval to help narcolepsy and sleep apnea patients stay awake. But the new drug can't roll onto the market until it clears a separate regulatory hurdle at the DEA.
FDA temporarily retreats from impurity standards as losartan shortages loom
Thu, 21 Mar 2019 12:17:22 +0000
The FDA, whose efforts to safeguard the U.S. drug supply have led to shortages of certain blood pressure drugs, is setting its own rules aside on a probable cancer-causing impurity. Drugmakers can make losartan with the impurity above its prescribed level for six months while the supply of clean drugs is ramped up.
C2 Pharma doubles down on supplies of digoxin API
Wed, 20 Mar 2019 17:44:06 +0000
C2 Pharma, which concentrates on hard-to-make ingredients, has picked up a new supply of digoxin. The deal will give it two supplies of API for making the sometimes difficult-to-get drug.
Merck KGaA investing €1B at headquarters site as part of 5-year work agreement
Wed, 20 Mar 2019 15:09:17 +0000
Merck KGaA’s headquarters site in Darmstadt, Germany, is the pride of its international operations, and it intends to keep it that way. The German drug and materials maker says it has nailed down new work agreements with employees there and will invest €1 billion in the site.
Novo Nordisk, aiming for approval this fall, puts first-ever oral GLP-1 drug up for FDA review
Wed, 20 Mar 2019 15:08:55 +0000
Novo Nordisk could use a blockbuster launch, and on Wednesday the company turned in its FDA application for a drug it hopes will be just that. And it asked FDA to clear oral semaglutide not only to treat diabetes but also to cut CV risks in those patients.
AbbVie faces class action lawsuit from New York grocery union over Humira 'patent thicket'
Wed, 20 Mar 2019 13:40:40 +0000
AbbVie’s efforts to protect its megablockbuster Humira have been well documented and much maligned, and now New York’s largest grocery union is taking the drugmaker to task over its “patent thicket” and “market division” agreements.
Thermo Fisher expands biologics manufacturing at 3 sites
Wed, 20 Mar 2019 12:44:02 +0000
With biopharmaceuticals dominating the drug development landscape, Thermo Fisher Scientific says it needs more capacity throughout its manufacturing network. To that end, its CDMO operations will invest $150 million in three sites.
See ya, Goodfella: #FierceMadness voters bounce Liotta, Tremfya and more in first-round play
Wed, 20 Mar 2019 12:32:05 +0000
First-round winners in the #FierceMadness ad tournament are decided, with the victors including Sun's Ilumya and AbbVie's Mavyret advancing to compete in Round 2's field of 32.
Pfizer, Merck KGaA scrap yet another Bavencio ovarian cancer trial
Wed, 20 Mar 2019 06:17:35 +0000
Pfizer and Merck KGaA have had a rough go at broadening immuno-oncology drug Bavencio's reach, and the pair are calling it quits on yet another late-stage trial—the third to bite the dust in ovarian cancer alone.
Merck's refreshed HPV vaccine push puts Mom in the spotlight
Wed, 20 Mar 2019 02:26:28 +0000
Merck continues its HPV awareness campaign with a twist. In a new TV ad, a parent serves as narrator for the first time in the three-year-old campaign, answering the previous commercials' "Did you know?" question. "I knew," says Mom, "So I talked to my doctor."
Sage wins OK for depression drug Zulresso. Up next? Major marketing challenges
Tue, 19 Mar 2019 18:04:45 +0000
Sage Therapeutics has the first-ever approval for a postpartum depression drug, thanks to the FDA’s Tuesday green light for Zulresso. But it also faces some big challenges in launching the new drug: its 60-hour infusion time, for instance.
Venclexta trial deaths force AbbVie, Roche to stop recruiting myeloma patients
Tue, 19 Mar 2019 15:18:14 +0000
AbbVie and Roche are looking to move key oncology drug Venclexta deeper into the blood cancer arena, but their ambitions just took a hit. After flagging deaths in a phase 3 multiple myeloma trial, the FDA put all of Venclexta's studies in that disease on partial hold.
Without 'smoking gun,' BMS, Celgene deal will close as planned: analyst
Tue, 19 Mar 2019 15:14:50 +0000
Starboard Value published a 197-page presentation tearing apart the proposed merger between Bristol-Myers Squibb and Celgene. But it lacked a "smoking gun," an analyst wrote, so the tie-up will likely go through.

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