By scooping up GlaxoSmithKline's Chiron Behring Vaccines subsidiary, Bharat Biotech has taken another step toward its goal of becoming the world's largest vaccine maker in terms of product numbers. Dr. Reddy's had one plant cleared but another one criticized by the FDA in a turbulent week that saw the Indian drugmaker's stock drop to a 17-year low. Sandoz has agreed to sell eight generics in the U.S. to Bangladesh's Beximco Pharma, as the Novartis subsidiary continues to refocus itself on higher-margin assets.
1. Bharat buys GSK’s Indian vaccine unit to become largest rabies shot producer
GSK is selling its India-based Chiron Behring Vaccines subsidiary to Bharat Biotech. The deal will make Bharat the world’s largest supplier of rabies vaccines with an annual capacity of 25 million doses, Bharat Chairman Krishna Ella said, according to Business Standard. Ella reportedly said the company expects to recover its investment in about five years.
2. Dr. Reddy's racks up more repeat violations at Bachupally formulations plant
Dr. Reddy’s oncology drug plant escapes cloud of FDA warning letter
It was good news, bad news week at Dr. Reddy’s. First, its formulations plant in Bachupally, India, was cited in an FDA Form 483 with 11 observations, sending its shares to a 17-year low on Feb. 15. Most of the observations centered on inadequate investigation of out-of-specification test results and customer complaints, according to Jefferies analysts. But then, the Indian drugmaker reported that its oncology plant in Duvvada, India, had been cleared by the FDA. That facility has also faced FDA scrutiny several times, preventing Dr. Reddy’s from launching some generic cancer drugs in the U.S.
3. Sandoz sells more U.S. generics to Bangladeshi firm amid portfolio shakeup
After selling some U.S. generic pills and its dermatology business to Aurobindo for $1 billion, Novartis’ Sandoz has agreed to hand eight generic drugs in the U.S. to Bangladesh's Beximco Pharmaceuticals for an undisclosed amount. The deal brings Beximco’s portfolio to 14 generics meant for the U.S. market, and the company said it will manufacture the drugs at its own Bangladesh site.
4. Philippine officials pull Dengvaxia's marketing license, but Sanofi asks them to reconsider
Citing “brazen defiance” and saying Sanofi failed to meet its post-marketing requirements, the Philippines FDA pulled Dengvaxia’s regulatory approval. The dengue vaccine stirred up much controversy since Sanofi's 2017 disclosure that the vaccine may cause serious infections in dengue-naïve people. Now, the drugmaker has filed a motion for reconsideration.
5. WuXi AppTec CDMO STA Pharma inks exclusive deal with Swiss biotech BioLingus
WuXi STA has signed a deal to get exclusive access to Swiss biotech BioLingus’ technology for sublingual and buccal delivery in the CDMO arena. The company’s oral delivery platform centers not only on small-molecule drugs but peptides and proteins as well.
Editor's Note: A previous version of the report mistakenly referred to Beximco as an Indian company.