Manufacturing

Sweden’s Xbrane Biopharma has delivered updates for two of its more long-term projects, including a proposed biosimilar to Bristol Myers Squibb’s Opdivo for which it is actively seeking a partner.

Manufacturers should keep a sharp eye on data from contract research organizations, looking for “any irregularities” amid a concerning trend of data integrity issues pertaining to BA/BE studies conducted by certain CROs in India, the director of the FDA’s drug center says.

Just-Evotec Biologics has announced an expansion of its partnership with Sandoz to develop and manufacture biosimilars.

Italy’s Olon Group has acquired French biotech contract development and manufacturing organization GTP Bioways, in a move that Olon says will allow it to “expand and diversify its technological offerings.”

While the European SPC manufacturing waiver was once seen as a triumph for the region’s off-patent industry, concerns are now being raised over how the mechanism is implemented. Attendees at Medicines for Europe’s legal affairs conference in Dublin last week heard the latest.

Hikma is not resting on its laurels after paying $375m upfront for US injectables specialist Custopharm two years ago, penning another acquisition agreement for a bundle of pharma and physical assets from Danish firm Xellia.

In a for-now limited pool of chasers, Sweden’s Xbrane Biopharma has unveiled a milestone and business update for its proposed biosimilar to Bristol Myers Squibb’s major PD-1 inhibitor, Opdivo.

The US FDA’s observations at its radiopharma manufacturing facility in Canada could be a headwind for Jubilant Pharmova, but reorientation of US generics manufacturing is expected to boost profits.

US HHS is proposing a public-private partnership to assign ratings to manufacturers based on quality/resilience of supply, tied to a purchasing incentive program for providers. The non-agency approach may be key to overcoming industry and political objections.

IntelGenx has once again been frustrated in its attempts to challenge Collegium’s powerful opioid Belbuca in the US, amid ongoing litigation over the brand’s three US patents that run until December 2032. Meanwhile, Teva’s desire to push on with its own January 2027 launch has been called into question.

Bora Pharmaceuticals has completed its takeover of Upsher-Smith from Sawai, with the acquisition opening up new US opportunities for the Taiwanese company including providing the firm with its first US manufacturing sites.

As Sandoz continues to fight against antimicrobial resistance, the firm opens a new production facility in Austria, strengthening its position in Europe with a vertically integrated production network for penicillin.

Alvotech stepped into its 2023 annual financing results call bursting with positive news and momentum, on the back of obtaining USFDA approval for its biosimilar Humira product and a bullish outlook for its strong pipeline of biosimilar candidates.

EuroAPI is on the backfoot once again after being forced to suspend production at its manufacturing site in Brindisi, Italy, weeks after unveiling a four-year strategic roadmap that sought to tighten and focus its operations amid a challenging two years.

Although the two Canadian off-patent industry bodies support new initiatives that expand drug coverage for Canadians, they remain cautious about the use of pricing schemes that could potentially affect drug supply of generics.

Ahead of a planned September UN meeting, the industry group and key companies demand concrete steps that could turn the tide in the fight against antimicrobial resistance.