Aurobindo

Hyderabad-based Aurobindo has put the Indian market in its sights with the $22.6 million acquisition of the domestic formulations business of Veritaz, Aurobindo announced Monday. Veritaz boasts around 40 brands in the acute and critical care therapeutic segments and is also headquartered in Hyderabad.

The acquisition will serve as a “launch pad for marketing biosimilar and other products in India,” Aurobindo said in its press release.

The state of the hunt:

The AstraZeneca/Oxford vaccine secured its first authorizations.
  Novavax launched a 30,000-participant North American Phase 3 trial for its recombinant vaccine.
  CNBG claimed 79% efficacy for the inactivated jab from its Beijing subsidiary but provided scant data.

 

Vaccines


Approved or authorized vaccines
 
UK authorizes AstraZeneca/Oxford jab: Britain’s Medicines and Healthcare products Regulatory Agency…

The state of the hunt:

With their mRNA vaccine showing an interim efficacy rate above 90%, Pfizer and BioNTech may have the necessary data to apply for U.S. FDA Emergency Use Authorization this month.
  Eli Lilly snagged the first FDA EUA for an anti-SARS-CoV-2 monoclonal antibody.
  Indonesia and Morocco laid out plans for Covid-19 mass immunization campaigns before year-end.

 

Vaccines


Phase 3 candidates:

Pfizer/BioNTech’s shot more…

The state of the hunt:

Phase 3 trials of AstraZeneca’s AZD1222 vaccine candidate resumed in Brazil, Britain, India and South Africa, while U.S. officials voiced safety concerns.
  The United Arab Emirates joined China in issuing emergency approval of a CNBG inactivated vaccine candidate.
  A trial of Lilly’s RA drug Olumiant in combination with remdesivir met its primary endpoint.

 

Vaccines

Phase 3 candidates:
 
Phase 3 trials resumed last…

Attorneys general from 51 U.S. states and territories filed a federal lawsuit last week against 26 drug manufacturers and 10 company executives for price-fixing and market allocation of at least 80 generic drugs in the United States between 2009 and 2016.

Led by Connecticut’s attorney general (AG), the lawsuit includes Teva subsidiary Actavis, Aurobindo, Glenmark, Lupin, Mylan, Pfizer, Sun and Wockhardt as well as Novartis subsidiary Sandoz—which agreed to a record $195 million…

Novartis announced last week that it has scrapped the planned $1 billion sale of its Sandoz subsidiary’s U.S. oral solids and dermatology businesses to Aurobindo. According to a company press release, “approval from the U.S. Federal Trade Commission for the transaction was not obtained within anticipated timelines.”

Were the deal—initially announced in September 2018—approved, Aurobindo would have become the second-largest generics company in the United States (based on number of…

The Coalition for Epidemic Preparedness Innovations (CEPI) announced last week that Aurobindo subsidiary Auro Vaccines’ recombinant subunit Nipah vaccine candidate HeV-sG-V has entered Phase 1 trials.

According to the press release, Maryland’s Emergent BioSolutions will produce the clinical trial material and has an exclusive option to license the shot and to “assume control of development activities.”

In May 2018, CEPI first announced up to $25 million of funding for the program…

India’s Aurobindo announced in a filing last week that its U.S. vaccines subsidiary will acquire $11.3 million of R&D assets from Maryland-based Profectus BioSciences. The company disclosed few details, but the filing noted that Profectus stands to earn milestone payments.

The Coalition for Epidemic Preparedness Innovations (CEPI) and the U.S. National Institute of Allergy and Infectious Diseases (NIAID) are among the funders of Profectus, a clinical-stage vaccine developer working…

Forty-four U.S. states filed a lawsuit in Connecticut last week against Israeli pharmaceutical Teva and 19 other generics manufacturers, accusing them of orchestrating a sweeping scheme to inflate drug prices, media reported.

Endpoints News said Mylan, Glenmark, Novartis subsidiary Sandoz, and Actavis are among the defendants, while India’s Economic Times reported Aurobindo is also included. Teva was at the center of the alleged collusion, which the lawsuit said was “one of the most…

GSK subsidiary ViiV Healthcare announced last week that it has submitted a regulatory application to the European Medicines Agency for its single-tablet, two-drug regimen of dolutegravir and lamivudine for treatment of HIV-1 infection. According to its press release, ViiV anticipates further regulatory submissions in the coming months, including a new drug application to the U.S. FDA in October using a priority review voucher.

Meanwhile, India’s media reported this week that Aurobindo…

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