Serum to hold 15% in Biocon arm Biocon Biologics as part of a broad alliance that expects to leverage the partners' strengths and resources in vaccines and biologics. Pursuing opportunities based on the hot mRNA technology platform appears firmly on the table.

Philip Morris once again pledged to up R&D in Vectura after its £1.1bn takeover offer for the UK-based inhalation specialist became unconditional, following the tobacco giant’s acrimonious face-off with private equity Carlyle earlier this year.

Lupin has agreed to pay $248m to settle the majority of antitrust claims against the company alleging that it caused and enabled the prolonged delayed launch of generic Glumetza, which subsequently saw a price hike of more than 800% by originator Valeant, now Bausch Health.

BioFactura, which is already using its ‘StableFast’ technology platform to develop its biosimilar ustekinumab candidate, has allied with fellow US-based biotech Rani Therapeutics to see if the biologic can be formulated into Rani’s proprietary ‘robotic’ pill.

India’s Alkem has delivered a strong quarter with a boost in its domestic business on the back of “strong volume-led growth in the acute therapies and faster than market growth in chronic therapies.” However, the company saw a slight YoY decline in the US.

Two former JHL Biotech executives, Racho Jordanov and Rose Lin, have been convicted in the US of conspiracy to commit trade secret theft and wire fraud after submitting plea agreements. Meanwhile, the company – now named Eden Biologics – has just announced a change of CEO.

The EU’s creation of a Health Emergency Response Authority to deal with future health threats has been welcomed by off-patent industry association Medicines for Europe. However, the organization pointed out current policy and regulatory weaknesses that must be addressed if HERA is to be successful.

The US FDA and EMA have announced a pilot program to provide parallel scientific advice on complex generics and hybrid medicines for prospective applicants, with a goal of harmonization and increased regulatory convergence.

The AAM has applauded US proposals to lower drug prices, following the development of the HHS’s 45-day plan in response to president Joe Biden’s executive order on promoting competition. However, AAM chief executive Dan Leonard has criticized Congressional proposals to weaken the 180-day incentive for first generics and curtail patent settlement agreements as “misguided.”

Senators press for sharing of FDA applications with PTO as Woodcock letter seeks collaboration on everything from PTAB to patent term extensions to ‘possible misuse of the patent system.’

Before the month is out, Alvotech hopes to hear back from the US FDA for its AVT02 high-concentration 100mg/ml biosimilar adalimumab candidate. The Icelandic firm, which remains embroiled in litigation with originator AbbVie, has reported top-line results from its key switching study. 

New guidance from UK's MHRA saying comparative clinical efficacy studies typically will not be needed is a start, but other regulators may need a few years before adopting similar rules.

Alvotech and Stada are on the verge of gaining the world’s second ever approval for a higher-strength Humira biosimilar, after the EMA’s CHMP endorsed the firms’ adalimumab under the names Hukyndra and Libmyris at its September meeting.

By allowing Amarin’s allegation of induced infringement against Hikma over its generic version of Vascepa to proceed, a US court is jeopardizing the ‘skinny label’ system that allows generics to carve out patented indications from their labels under the Hatch-Waxman framework, according to the AAM.

Lupin has agreed to pay $248m to settle the majority of antitrust claims against the company alleging that it caused and enabled the prolonged delayed launch of generic Glumetza, which subsequently saw a price hike of more than 800% by originator Valeant, now Bausch Health.

Alvotech and Stada are on the verge of gaining the world’s second ever approval for a higher-strength Humira biosimilar, after the EMA’s CHMP endorsed the firms’ adalimumab under the names Hukyndra and Libmyris at its September meeting.

New Zealand’s Pharmac pharmaceutical management agency is considering funding Amgen’s Amgevita adalimumab biosimilar rather than the Humira reference brand from early 2022.

Ahead of launching potentially its Lucentis biosimilar in the EU early next year, Samsung Bioepis has reported two lots of positive analysis involving its Byooviz biosimilar, at the same time as it disclosed the findings of a five-year follow-up study for its trastuzumab biosimilar, Ontruzant.

The US FDA and EMA have announced a pilot program to provide parallel scientific advice on complex generics and hybrid medicines for prospective applicants, with a goal of harmonization and increased regulatory convergence.

BioFactura, which is already using its ‘StableFast’ technology platform to develop its biosimilar ustekinumab candidate, has allied with fellow US-based biotech Rani Therapeutics to see if the biologic can be formulated into Rani’s proprietary ‘robotic’ pill.

Intas and Arecor have struck an exclusive licensing deal that will see the pair use Arecor’s proprietary Arestat formulation technology to develop value-added medicines, in particular for use outside of the hospital setting.