FiercePharma: Pharma
AbbVie scores blockbuster approval for RA med Rinvoq, its crucial Humira follow-up
Fri, 16 Aug 2019 18:02:32 +0000
The second of AbbVie’s highly anticipated 2019 blockbuster candidates is here. Friday, the FDA greenlighted Rinvoq, a rheumatoid arthritis med meant to succeed best-selling Humira as copycats bite into its sales. The new product should be available in the U.S. by late August, AbbVie said.
In a boon for buyer Bristol-Myers, Celgene's JAK med Inrebic scores FDA nod
Fri, 16 Aug 2019 15:30:09 +0000
Bristol-Myers Squibb’s $74 billion Celgene takeover has been a roller coaster, with some Revlimid patent wins on the upside and, on the down, an FTC-forced sale of blockbuster Otezla. But the FDA just handed the merger partners another win.
Investors angry about insulin woes sue Novo Nordisk in Denmark for $1.75B
Fri, 16 Aug 2019 14:54:08 +0000
A group of investors sued Novo Nordisk in Denmark for allegedly misleading the public about its insulin franchise's downward spiral. The lawsuit claims $1.75 billion in losses as pricing pressures and falling sales sent share prices downward—and as Novo points out, broadly resembles a shareholder suit filed in the U.S.
Debt-laden Glenmark counts on assets sales, spinoffs to dig it out
Fri, 16 Aug 2019 14:50:53 +0000
Glenmark Pharmaceuticals’ makeover is painfully loaded with slow revenue growth and high capital spend simultaneously. In the hope of reducing debt, the Indian drugmaker now plans to sell some of its noncore assets after spinning off its API and innovative R&D businesses.
Another hit for Roche: UnitedHealthcare backs Amgen biosims over blockbuster oncology meds
Fri, 16 Aug 2019 14:05:53 +0000
Two of Roche’s oncology blockbusters, Herceptin and Avastin, are facing dire straits as first-ever biosim competitors have entered the U.S. market. Now, a major insurer is putting its money on the new guys. Amgen's new guys, to be exact.
Bausch may have shed the Valeant name, but it still leans on price hikes: analyst
Fri, 16 Aug 2019 13:23:51 +0000
Valeant changed its name to Bausch Healthcare last year to distance itself from controversy, but one of the company's old strategies—using price hikes to boost revenue—hasn't gone anywhere, an analyst writes.
FiercePharmaAsia—Lowest-paid Indian pharma CEO; Dr. Reddy's CRL; Natco's double whammy
Fri, 16 Aug 2019 10:38:30 +0000
Sun Pharma's Dilip Shanghvi got only 1 rupee in salary last year. The FDA refused to approve Dr. Reddy's generics of Copaxone and NuvaRing. India's Natco says it's looking to China and other emerging markets for future growth. And more.
Ready to rumble: Roche scores Rozlytrek OK to challenge Bayer—and undercuts it on price
Thu, 15 Aug 2019 21:14:59 +0000
Roche’s targeted cancer drug Rozlytrek officially has its U.S. green light—and in not just one but two cancer types. Thursday, the FDA cleared the med to treat ROS1-positive non-small cell lung cancer and tough-to-treat NTRK fusion-positive tumors.
Sanofi defends top oncology drug with Jevtana patent win
Thu, 15 Aug 2019 14:53:14 +0000
Sanofi has been battling against generics companies over patents to Jevtana, its top oncology product. In the latest round, the company scored a win to defend a 2021 patent and a 2031 patent. The company convinced an appeals court to overturn a prior loss it suffered on a 2031 patent.
Pfizer recalls migraine med Relpax because of bacterial contamination
Thu, 15 Aug 2019 14:04:18 +0000
After an earlier recall of Relpax, Pfizer is again tracking down a couple of lots of the migraine headache med. This time, it's because the affected drugs may be contaminated with bacteria that could cause fatal infections in some patients.
Teva shares approach 20-year low amid Moody's warning and other woes
Thu, 15 Aug 2019 13:53:55 +0000
Debt-rating firm Moody's revised its Teva outlook from "stable" to "negative" as the company deals with challenges ranging from opioid lawsuits to a congressional price-fixing probe to declining Copaxone sales. Investors were none too happy.
Emcure knocked by the FDA for sterility issues after injectable drug recall
Thu, 15 Aug 2019 12:51:41 +0000
Emcure Pharmaceuticals has had its share of run-ins with the FDA in the past over the sterility of its Indian manufacturing plant. Now, it can notch one more black mark on its belt.
FDA cites solvent recovery firm as a player in the valsartan mess
Thu, 15 Aug 2019 11:43:07 +0000
The FDA upended the entire landscape for makers of sartan-based blood pressure medicines after finding some contained potential carcinogens. Now, the FDA is trying a new tack. 
Amarin tests Vascepa campaign in preparation for label update
Thu, 15 Aug 2019 00:17:48 +0000
Amarin may still be waiting for the FDA to include new risk-reduction info to Vascepa's label, but in the meantime, it's getting prepared. The company is testing a pilot TV and digital ad program in select markets for the triglyceride fighter.
Harmony Biosciences scores first approval in narcolepsy med Wakix
Wed, 14 Aug 2019 19:09:39 +0000
After two years of preparations and building up its infrastructure, Harmony Biosciences is ready for its first-ever drug launch. The FDA Thursday green-lighted Wakix, or pitolisant, to treat daytime sleepiness in adults suffering from narcolepsy.
Allergan CEO Saunders lines up for $39M parachute after AbbVie buy
Wed, 14 Aug 2019 15:43:46 +0000
Allergan CEO Brent Saunders’ meteoric rise through pharma’s chief exec ranks is paying off, and in a big way. If he’s let go after AbbVie’s $63 billion takeover of the California company goes through, Saunders will net a cool $38.7 million.
Which pharmas grew most in Q2? AstraZeneca, Merck and BMS, for 3
Wed, 14 Aug 2019 14:32:58 +0000
As pharma's earnings reports rolled out for the second quarter, market watchers pointed out a big positive: Growth rates, for many companies at least, were up. Way up. We've ranked the major players, from Regeneron's 20% sales hike to Teva's 8% drop.
Dr. Reddy's Copaxone, NuvaRing generics derailed by FDA 
Wed, 14 Aug 2019 14:16:47 +0000
Dr. Reddy’s, which has been dealing with repeated manufacturing setbacks from the FDA, is now facing a new regulatory challenge. It has received a complete response letter for two potentially very lucrative products.
Regeneron plots $800M New York production push—along with 1,500 new jobs
Wed, 14 Aug 2019 14:09:55 +0000
Regeneron is humming along on the strength of flagship eye med Eylea and fast-launching immunology drug Dupixent. Now, the drugmaker is dropping $800 million into its New York operations to keep up with the growth. Regeneron is planning a statewide expansion of its production facilities, including the final phase of its East Greenbush site.
AZ, Merck's latest Lynparza combo win could widen its ovarian cancer reach
Wed, 14 Aug 2019 14:04:35 +0000
In the red-hot market for PARP inhibitors, AstraZeneca and Merck’s contender Lynparza is ahead of rival products from GlaxoSmithKline and Clovis Oncology—but not comfortably ahead. That may change, though, thanks to news from a key clinical trial in ovarian cancer that the partners released today.

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