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Today's Rundown

'Up to Paul now': Galapagos' new CEO Stoffels jumps straight into deal talks, finding a new science chief
Provention's med for delaying diabetes wins go-ahead for FDA resubmission
FDA expands oversight over TG's stalled U2 cancer combo therapy, sinking shares
Yet another delay at Amryt as EMA calls in experts to inform review of rare disease drug
Homology scratches cash itch with manufacturing deal, bagging $130M to fund gene therapy trials
Samsung buys Biogen out of biosimilar unit for $2.3B—not the whole Aduhelm headache
GAO calls for major reforms at HHS to better prepare for future health emergencies
BioVentrix snatches up MateraCor for a hydrogel-based approach to heart failure
Unable to 'align' with FDA, Regeneron, Sanofi pull application for Libtayo in cervical cancer days before decision date
Chutes & Ladders—Ex-J&J science chief returns to troubled Galapagos as CEO
Fierce Pharma Asia—Samsung Biologics' mRNA ambition, GSK COVID-19 vaccine supply; Fujifilm's plant buy

Featured Story

'Up to Paul now': Galapagos' new CEO Stoffels jumps straight into deal talks, finding a new science chief

By Kyle LaHucik

Galapagos' new CEO, Paul Stoffels, M.D., is ready to jump into acquisition and partnership talks and review new chief science officer candidates as he oversees a much-needed turnaround for the 23-year-old biotech.

Provention's med for delaying diabetes wins go-ahead for FDA resubmission

By Annalee Armstrong

Provention Bio has won the go-ahead from the FDA to resubmit its application for a therapy to delay diabetes, which has been on hold since the agency questioned whether the planned commercial product was comparable to the drug used in historical trials.

FDA expands oversight over TG's stalled U2 cancer combo therapy, sinking shares

By Kyle LaHucik

The FDA told TG Therapeutics to halt enrollment in some trials of its U2 cancer combo treatment, which includes the approved relapsing lymphoma med Ukoniq, sinking shares by 43%.

Yet another delay at Amryt as EMA calls in experts to inform review of rare disease drug

By Nick Paul Taylor

The delays keep coming at Amryt. After seeing approval decision dates for its rare skin disorder drug slip on both sides of the Atlantic late last year, Amryt has now reported a further two-month delay to the European Medicines Agency’s (EMA) decision about Oleogel-S10.

Homology scratches cash itch with manufacturing deal, bagging $130M to fund gene therapy trials

By Nick Paul Taylor

Homology Medicines has found a source of fresh funding. With its share price in the doldrums and its cash runway nearing its final year, Homology is offloading manufacturing assets through a joint venture to raise $130 million for clinical development of gene therapies.

Samsung buys Biogen out of biosimilar unit for $2.3B—not the whole Aduhelm headache

By Angus Liu

A recent report from Korea buzzed a Biogen takeover by Samsung. Turns out, Samsung is indeed buying something of Biogen’s, just not the entire company that’s saddled with the Alzheimer’s drug launch trouble.

GAO calls for major reforms at HHS to better prepare for future health emergencies

By Robert King

The GAO is worried that longstanding issues at HHS will cause the agency to bungle future public health emergencies and calls for several reforms.

BioVentrix snatches up MateraCor for a hydrogel-based approach to heart failure

By Conor Hale

For an undisclosed amount, the former Fierce 15 winner has bought up MateraCor, a California startup developing a hydrogel injection for strengthening the heart muscle wall.

Unable to 'align' with FDA, Regeneron, Sanofi pull application for Libtayo in cervical cancer days before decision date

By Kevin Dunleavy

With a Jan. 30 target date fast approaching for approval of Libtayo as a second-line treatment in cervical cancer, Regeneron and Sanofi have voluntarily withdrawn their application. The companies and the FDA were not “able to align on certain post-marketing studies," Regeneron and Sanofi said.

Chutes & Ladders—Ex-J&J science chief returns to troubled Galapagos as CEO

By Kyle LaHucik

Galapagos poached former Johnson & Johnson Chief Scientific Officer Paul Stoffels, M.D., who will become CEO April 1 as 23-year-veteran CEO Onno van de Stolpe retires. CytoDyn ousted its CEO and shuffled its board following multiple setbacks, including scrutiny from the FDA, DOJ and SEC. Atomwise named a new CSO, CFO and general counsel.

Fierce Pharma Asia—Samsung Biologics' mRNA ambition, GSK COVID-19 vaccine supply; Fujifilm's plant buy

By Angus Liu

Samsung Biologics is building a fifth plant for cell and gene therapy and mRNA vaccines. The Korean CDMO recently won FDA clearance to help make GlaxoSmithKline and Vir Biotechnology's COVID-19 antibody drug. Fujifilm is buying a new cell therapy plant. And more.