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Today’s Big News

Aug 8, 2024

After a tough year, Exscientia folds into Recursion to create an AI superpower

Apellis, Sobi's 'enormous' Empaveli win could pressure Novartis in rare kidney diseases: analyst

'All hands on deck' at Lilly as competitors come for obesity market

Medtronic recalls nerve monitoring tech linked to 10 patient injuries

FDA blasts Bristol Myers over misleading Krazati efficacy claims

Featured

After a tough year, Exscientia folds into Recursion to create an AI superpower

By Annalee Armstrong

After a year defined by pipeline cuts, the departure of its CEO and layoffs, Exscientia will merge into Recursion, creating one company that has 10 clinical readouts to look forward to over the next 18 months.

Apellis, Sobi's 'enormous' Empaveli win could pressure Novartis in rare kidney diseases: analyst

By Zoey Becker

Empaveli showed strong efficacy in two rare kidney diseases. The result “exceeded our already high expectations," an Apellis exec said, and it led analysts at Evercore ISI to assign the drug a majority future market share against Novartis’ rival.

'All hands on deck' at Lilly as competitors come for obesity market

By Annalee Armstrong

CEO David Ricks can see the companies setting up tents at basecamp behind Eli Lilly in an attempt to get a foothold of the obesity market. But Lilly's already been to the summit and is coming back down for another trip.

Medtronic recalls nerve monitoring tech linked to 10 patient injuries

By Heather Landi

The FDA is alerting healthcare providers to a medical device recall from Medtronic for its nerve monitoring system that has been linked to 10 injuries.

FDA blasts Bristol Myers over misleading Krazati efficacy claims

By Nick Paul Taylor

The FDA has taken Bristol Myers Squibb to task for making false or misleading claims about the efficacy of Krazati on the website for the KRAS cancer drug.

Novartis' IgAN ambition takes shape with expanded FDA nod for Fabhalta

By Angus Liu

The first horse carrying Novartis’ immunoglobulin A nephropathy troika has crossed the FDA finish line.

Still feting donanemab approval, Lilly faces phase 2 failure of tau-targeting med

By Annalee Armstrong,James Waldron

The confetti is still flying from Eli Lilly’s party celebrating the approval of Alzheimer’s med, but the company is yet again facing the harsh reality of the neurodegenerative disease with the failure of an early tau-targeting med.

Novo Nordisk found in breach of UK marketing rules with 2022 CEO interview on Wegovy

By Andrea Park

Amid its two-year suspension from the Association of the British Pharmaceutical Industry, the U.K.’s pharma trade group, following a series of breaches of the organization’s code of practice, Novo Nordisk is once again in hot water with the U.K.’s marketing watchdog.

Citius notches first FDA approval, scoring with Lymphir for cutaneous T-cell lymphoma

By Kevin Dunleavy

A year after it was hit with a rejection from the FDA, Citius Pharmaceuticals has won over the U.S. regulator, scoring an approval for Lymphir to treat relapsed or refractory cutaneous T-cell lymphoma in patients who've tried at least one prior systemic therapy.

Merck stops phase 3 TIGIT trial in lung cancer for futility—and sees immune side effects again

By Nick Paul Taylor

Merck & Co.’s TIGIT program has suffered another setback. Months after shuttering a phase 3 melanoma trial, the Big Pharma has terminated a pivotal lung cancer study after an interim review revealed efficacy and safety problems.

England's NICE clears Vertex, CRISPR's Casgevy in beta thalassemia after passing on sickle cell use

By Zoey Becker

The cost-effectiveness regulator recommended government funding for the groundbreaking gene editing therapy in one of its two approved indications.

Clinigen snaps up Kinesys Consulting to boost regulatory offering

By Ben Adams

London-based firm Clinigen is adding to its roster of biopharma services with the acquisition of regulatory affairs specialist Kinesys Consulting.

Fierce podcasts

Don’t miss an episode

'The Top Line': Fierce 15: Where are they now?

In this week’s episode of "The Top Line," Fierce Biotech’s Annalee Armstrong highlights some of the most promising companies that made our prestigious Fierce 15 list back in 2014.

'The Top Line': Former FTC director weighs in on Novo's $16.5B deal with Catalent

Podnosis’: New mandatory bundled payment model for hospitals

Resources

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2024 Life Sciences Industry Outlook

The definitive report on the state of our industry. Readers will gain an understanding of key indicators to monitor, future predictions, and guidance for investors and founders navigating the therapeutic enabling tools and services, healthtech and techbio sectors through 2024 and beyond.