Generic drug producer Mylan has had some manufacturing issues of late that have resulted in recalls of cancer drugs made for Pfizer. Now it finds itself in the reverse situation. Mayne Pharma is recalling more than 74,000 bottles of a topical pain drug used in cataract surgeries that it manufactured but which is licensed to and sold by Mylan.
Mylan's Agila Specialties, which has already had production at three Indian plants affected by an FDA warning letter, stopped manufacturing at its Poland facility last fall after health inspectors there found major issues with the plant's sterile manufacturing areas.
SAN FRANCISCO-- On Monday, we brought you the lowdown from the J.P. Morgan Healthcare Conference, with company presentations from pharma giants including Novartis and Merck & Co. Today, we're back with our latest roundup, big names and not-so-big.
UPDATED: Perrigo recalls store brands of popular Zyrtec, Mucinex meds it makes for CVS, Kroger and others
Perrigo is having to strip from retailers' shelves hundreds of thousands of packages of its copy of number-one allergy pill Zyrtec that are sold through CVS, Kmart, Kroger, and other retailers large and small. Perrigo initiated the recall of the antihistamine in late September after it found that the products potentially contained an impurity.
On Friday, Vectura said it had wrapped up clinical trials for an Advair generic dubbed VR315, which could take on GSK's respiratory behemoth in early 2018. Now, the company will "look forward to submission of the file, positioning VR315 competitively in what will be a major value opportunity," Vectura chief James Ward-Lilley said in a statement.
Mylan has stepped up to partner with Cambridge, MA-based Momenta Pharmaceuticals on a portfolio of 6 biosimilars, handing over a $45 million upfront, a commitment to cover half of the costs and a promise to provide up to $200 million more in milestones. The two partners will also split any profits.
Investors look for Pfizer, Allergan, Mylan, Baxalta and others to address big questions at JP Morgan conference
There are big questions facing some of pharma's key players this year, like whether the Pfizer and Allergan deal will get done and why Allergan thinks that is its best route. Or what Mylan intends to do since it spurned a buyout from Teva but failed to close on Perrigo. At least some of those can be expected to be answered next week when nearly all of pharma, large and small, convene in San Francisco for the JP Morgan Healthcare Conference.
Mylan recently got hammered by the FDA in a warning letter for three plants that it acquired as part of its $1.75 billion acquisition of the sterile injectables business of what was then Strides Arcolabs. Now Mylan is apparently looking for Strides to cough up some of the cost of getting those plants back into shape.
Mylan may have some EpiPen competition out of the way right now in recently recalled Auvi-Q from Sanofi, but that doesn't mean the drugmaker is letting up on the social media marketing front.
Mylan said today that it got a special delivery from the Justice Department Thursday, making it the most recent of a string of drugmakers to get a subpoena from federal investigators. In a one-sentence filing today, Mylan said the DOJ is asking for info about sales of the antibiotic doxycycline.