Struggling US firm Aceto has filed Chapter 11 bankruptcy petitions at the same time as agreeing to divest its chemicals business assets for US$338 million, with plans to also offload its Rising Pharmaceuticals unit.

Acino has bolstered its senior management team with four appointments, as the Swiss firm aims to strengthen its position as a high-quality pharmaceutical company focusing on emerging markets.

A recovery in the US, aided by abating pricing pressure and portfolio exits by some large players, augurs well for Indian firm Lupin, but impending new launches including levothyroxine will need to deliver to sustain US momentum.

Dr Reddy’s has been given the all-clear for its Indian formulations manufacturing facility in Duvvada, Visakhapatnam, after the FDA issued an EIR closing out an inspection at the plant that has suffered longstanding quality issues.

Alvogen and Dr Reddy’s have launched generic versions of Indivior’s Suboxone in the US, after the Supreme Court denied the originator’s attempt to further frustrate generic launches. But these two versions will compete with an authorized generic launched by Indivior through Sandoz.

Modifying terms to a 2015 consent decree involving its Cephalon unit, Teva has reached a global settlement agreement with the US Federal Trade Commission that dismisses Teva and its affiliates from three outstanding antitrust cases.

Pfizer has received a pan-European marketing authorization for its Zirabev biosimilar bevacizumab, a rival to Genentech’s Avastin. The nod marks Pfizer’s second European approval for an oncology biosimilar.

In response to FDA draft guidance reclassifying certain NDA “drugs” as BLA “biologics,” Eli Lilly is asking the FDA to clarify whether regulatory mechanisms exist for biological product sponsors to introduce ‘second versions’ of their innovative biological products.

Health Canada’s decision to not add a suffix to non-proprietary names for biologics, including biosimilars, has left the US as the only major territory to operate such a convention. The move has been welcomed by the Canadian generics industry.

Draft guidance on the approval pathway for competitive generic therapies (CGTs) has been published by the FDA in the agency’s latest move to advance generic drug competition.

By facilitating stock movements by enabling patients to access local-language product information digitally, plans to implement e-leaflets in Europe could also help to alleviate product shortages, the president of Medicines for Europe has suggested.

Alvogen and Dr Reddy’s have launched generic versions of Indivior’s Suboxone in the US, after the Supreme Court denied the originator’s attempt to further frustrate generic launches. But these two versions will compete with an authorized generic launched by Indivior through Sandoz.

Teva chief Kåre Schultz has set out his vision for the company to be a world leader in generics, complex generics and biologics, even as he continues to cut staff and shut manufacturing sites as part of cost-cutting measures. In the meantime, the firm faces a “trough year” in 2019, and its profitability is continuing to suffer due to impairments including charges linked to its acquisition of Actavis in 2016.

Mithra has produced its first commercial batch of Myring (ethinylestradiol/etonogestrel) for the European market at its CDMO facility in Belgium, soon after striking a 20-year license and supply agreement with ITROM Pharmaceutical Group to sell the combined hormonal contraceptive vaginal ring in the Middle East.

Pfizer has received a pan-European marketing authorization for its Zirabev biosimilar bevacizumab, a rival to Genentech’s Avastin. The nod marks Pfizer’s second European approval for an oncology biosimilar.

Teva chief Kåre Schultz has set out his vision for the company to be a world leader in generics, complex generics and biologics, even as he continues to cut staff and shut manufacturing sites as part of cost-cutting measures. In the meantime, the firm faces a “trough year” in 2019, and its profitability is continuing to suffer due to impairments including charges linked to its acquisition of Actavis in 2016.

In response to FDA draft guidance reclassifying certain NDA “drugs” as BLA “biologics,” Eli Lilly is asking the FDA to clarify whether regulatory mechanisms exist for biological product sponsors to introduce ‘second versions’ of their innovative biological products.

Pfenex maintains it can introduce a follow-on version of Eli Lilly’s Forteo in the fourth quarter of this year, after receiving a target goal date of 7 October 2019 from the FDA.

As the CHMP refuses to recommend granting approval for TLC’s doxorubicin hybrid, the committee within the EMA has given the nod to Teva’s Ajovy monoclonal antibody migraine remedy as well as two small-molecule generics from Krka.