The sun shines over a sector with multi-blockbuster products in their prime. But clouds are looming, and highly innovative products that cannot replace the sales shortfalls could lead to a re-rating of the sector’s growth prospects.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Public Company Edition: Cullinan and Cidara shifted their strategic directions and found investors to bring along for the ride. Also, Intra-Cellular closed a post-Phase III $575m follow-on offering and Tarsus accessed up to $200m from Pharmakon.

Recent moves in the industry include new chief executive officers at Medisca, Anthos Therapeutics and Systimmune.

Ono’s just-announced purchase of Deciphera has put the tenosynovial giant cell tumor space under the spotlight and SynOx is making strides to stay at the head of the pack helped by significant financing.

UK-based Ochre Bio has signed its first major deal with Boehringer Ingelheim. Scrip talked to its co-founder and CEO, Jack O’Meara, about its human tissue-based drug discovery platform, its resulting RNA platform for liver disease and how the fledgling drug company's early work mirrored that seen in diagnostics.

Ichnos Glenmark Innovation’s president and CEO talks to Scrip about the promising activity profile of the alliance’s early stage trispecific antibody versus Janssen’s teclistamab and also maintains that the setback for Gilead’s magrolimab hasn’t eclipsed prospects for its bispecific antibody.

Bristol Myers Squibb’s head of major markets, Monica Shaw, wants to improve patients’ access to lifesaving therapies. And the group has several new products ready to roll.

Pfizer/BioNTech’s COVID-19 vaccine Comirnaty toppled after recording the highest ever annual sales for a pharmaceutical in 2022, while Novo Nordisk’s Ozempic climbed rapidly. But Merck & Co’s immuno-oncology blockbuster Keytruda was secure in the number one spot in 2023 as COVID-19 receded.

The highs of the COVID-19 era, and the lows that supplanted it, are beginning to fade.

A year is a long time in biopharma. Pharmaprojects’ annual pipeline review finds changes in the therapeutic spread of drug candidates and a reordering of the top R&D companies, as Chinese firms made their presence felt all the more over the past 12 months.

A look at the depth of clinical responses seen with various MASH therapies suggests that Madrigal could eventually face serious competition.

Mounjaro revenue declined versus Q4 2023, Lilly reported, though grew 218% year-over-year. The pharma pledged significant ramp-up of manufacturing this year.

The US FDA recently initiated class safety labeling changes after evaluating the safety of CAR-T cancer treatment therapies. What does this mean for developers in the CAR-T landscape? Listen to your free podcast to find out.   

The sun shines over a sector with multi-blockbuster products in their prime. But clouds are looming, and highly innovative products that cannot replace the sales shortfalls could lead to a re-rating of the sector’s growth prospects.

Ono’s just-announced purchase of Deciphera has put the tenosynovial giant cell tumor space under the spotlight and SynOx is making strides to stay at the head of the pack helped by significant financing.

In this week's podcast edition of Five Must-Know Things: 2023’s top selling drugs and the COVID cliff; falling sales force Roche to reassess priorities; Phase III immunology win for Sanofi; BMS’s strong pipeline: and which companies could be acquired next.

A China green light for domestic firm Avistone's c-Met inhibitor was based on positive outcomes from the Phase II/III FUGEN study in Chinese patients with recurrent relapsing glioma with the rare PTPRZ1-MET fusion gene. Avistone’s overseas partner Apollomics is also studying the molecule in a Phase II program outside China.

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. Scrip takes a look at the likely impact.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

More legal action in India that has the Bolar exception provision at its crux with Roche, in this instance, warding off a local drug maker in the Evrysdi patent infringement case.

Public Company Edition: Cullinan and Cidara shifted their strategic directions and found investors to bring along for the ride. Also, Intra-Cellular closed a post-Phase III $575m follow-on offering and Tarsus accessed up to $200m from Pharmakon.

With adalimumab biosimilar market share increasing in the US, AbbVie says revenue erosion is on its expected pace, driven mainly by discounts. Skyrizi, Rinvoq continue growth trajectories.

The drug maker said the program would allow for continued reimbursement when patients change insurance plans. A Sangamo-partnered gene therapy for hemophilia A is also in the works.