December 13, 2019 - Fierce Pharma
The FDA’s attitude toward Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) therapies is nothing short of dramatic. In just four months, the agency shocked industry watchers twice, first with a rejection and now a reversal for the biotech’s Exondys 51 follow-on.
Out of nowhere, the agency Thursday
granted accelerated approval
to Sarepta’s Vyondys 53 (golodirsen), a drug it turned down in August for safety reasons. The go-ahead covers about 8% Duchenne patients whose dystrophin gene bears a certain mutation amenable to exon 53 skipping.
While the FDA didn’t elaborate on the sudden change of course, Sarepta said it had
launched
a formal dispute resolution request after receiving the agency's complete response letter (CRL) detailing its reasons for the rejection.
December 11, 2019 - Fierce Pharma
Just months after a C-suite shakeup at Amneal, the generics company has struck a $220 million deal that will not only fill capacity and boost its generics business but is set to disrupt the contract manufacturing market. That is because it is buying a majority stake in AvKare, which sources the private-label drugs it sells the government through dozens of contractors.
Amneal
says
it is buying a 65.1% stake in the Fountain Run, Kentucky-based business which will become a standalone subsidiary of Amneal. It says the deal sets the enterprise value of AvKare at $340 million. AvKare does business as R&S Northeast.
December 11, 2019 - Fierce Pharma
Bayer’s eager to send its animal health unit to Elanco so it can focus its healthcare efforts on pharmaceuticals. But that $7.6 billion selloff, like many other recent life sciences deals, has hit an antitrust snag.
The U.S. Federal Trade Commission
sent Elanco
a second request for information about the deal, the Indiana-based veterinary specialist said Monday.
December 10, 2019 - BioPharma Dive
The launch of AbbVie and Johnson & Johnson's Imbruvica transformed treatment of the blood cancer chronic lymphocytic leukemia, helping patients stay disease free for years with a pill rather than chemotherapy combinations.
But with several years of real-world experience, physicians now know that low-frequency side effects like irregular heartbeat and high blood pressure detected in clinical trials are bigger problems for patients on years-long courses of Imbruvica, the first of a class of drugs called Bruton's tyrosine kinase, or BTK, inhibitors.
December 19, 2019 - Fierce Biotech
Merck is set to
buy
ArQule for $2.7 billion. The planned takeover centers on ARQ 531, a BTK inhibitor that triggered durable responses in patients with B-cell malignancies in an early-phase trial.
ArQule has had plenty of ups and downs over its more than 20 years on public markets but has now found an exit. Merck has agreed to pay $20 a share, a more than 100% premium over ArQule’s Friday closing price, to buy the drug developer, primarily for midphase BTK inhibitor ARQ 531.
