Europe’s pharmaceutical industry has warned the conflict in Ukraine is disrupting supplies of medicines and clinical trials, while pledging free medicines to the humanitarian effort to those caught in or fleeing from the Russian invasion. A representative of the European Federation of Pharmaceutical Industries and Associations, which has an affiliate in Ukraine, told BioWorld that the disruption has left pharma industry staff in that country taking to emergency shelters.

Viatris agrees to takeover by biosimilars partner Biocon in $3.3B-plus deal

Biocon Ltd. subsidiary Biocon Biologics Ltd. (BBL) is buying out partner Viatris Inc. to bring aboard the latter's biosimilars business for $3.34 billion, including cash of $2.34 billion and compulsorily convertible preference shares in BBL, valued at $1 billion. The deal, approved by the boards of both firms, gives BBL access to Viatris’ global commercial setup, with revenues estimated next year at $1 billion. BBL shares (NSE:BIOCON) were trading at INR349.60 (US$4.63), down INR44.95, or 11%. Viatris’ stock (NASDAQ:VTRS) was selling for $11.17, down $3.37, or 23.1%.

Heidelberg Pharma finds fresh capital, path to Asia, in $1.1B Huadong Medicine deal

LONDON – Antibody drug conjugate (ADC) specialist Heidelberg Pharma AG has secured a route into Asia and a fresh injection of much-needed capital, in a licensing and equity deal with Huadong Medicine Co. Ltd. worth up to €930 million (US$1.1 billion). Huadong is taking an exclusive license to two products, HDP-101, which is in phase I/II trials in the U.S. and Germany, and HDP-103, which will be filed for an IND in 2023. The agreement also grants exclusive rights to opt into two more programs. These elements of the deal have a potential value of €825 million.

Celyad pauses phase Ib trial in colorectal cancer in latest CAR T solid tumor setback

Reports of two patient deaths prompted Celyad SA to voluntarily pause a phase Ib trial testing its allogeneic CAR T-cell therapy, CYAD-101, in combination with Keytruda (pembrolizumab, Merck & Co. Inc.) in patients with refractory metastatic colorectal cancer. Further investigation is ongoing, and the Belgian company provided few details beyond the fact that both deaths presented with similar pulmonary findings. But the latest clinical halt, coming barely 10 days after Atara Biotherapeutics Inc. reported a fatal adverse event in a phase I trial testing its autologous CAR T therapy, highlights the challenges of advancing CAR T therapies beyond hematological malignancies.

US FDA issues CRLs to Reata, Amryt and GC Pharma

Despite Reata Pharmaceuticals Inc.'s complete response letter (CRL) for bardoxolone in treating kidney function loss in those with Alport syndrome, the street is treating it well at midday. The stock (NASDAQ:RETA) is up about 18% as the company decides how it wants to handle the CRL. Amryt Pharma plc, of Dublin, on the other hand, is seeing the CRL it received for Oleogel-S10 to treat a rare skin disease hammer its stock at midday. Company shares (NASDAQ:AMYT) were trading down 20%. Also down, though less so, is GC Pharma Corp., of Yongin-si, South Korea. It received a CRL regarding its BLA for GC-5107 to treat primary humoral immunodeficiency. The stock (KOSPI:006280) dropped 6% as the U.S. FDA recommended a pre-license inspection of GC’s Ochang, Korea, facility to support the application's approval.

GSK halts enrollment and vaccination on three RSV vaccine trials

Shares in Glaxosmithkline plc ticked down after the U.K. pharma announced that enrollment and vaccination on three trials of its respiratory syncytial virus (RSV) maternal vaccine will stop, after a safety issue prompted a voluntary pause last week. In a brief statement the London-based company said the phase III Grace trial and two smaller trials were affected.

HHS: More work to do as drug, device supply chains recover

The U.S. is making strides in addressing the drug and device supply chain vulnerabilities revealed by the COVID-19 pandemic, but there’s still a lot of work to do to reduce dependance on sole source suppliers and foreign manufacturing, according to a new Health and Human Services (HHS) report. “Our reliance on manufacturing overseas created significant medical supply shortages for health care workers and put the health and security of the American people in danger,” HHS Secretary Xavier Becerra said. While much of the report is a pat on the back for advances made in the past year, it also points to what could be a long road ahead to fully address continuing challenges.

Henlius licenses adalimumab biosimilar to Pakistan’s Getz Pharma for $8M

Shanghai Henlius Biotech Inc. has licensed its adalimumab biosimilar Handayuan to Getz Pharma Pvt. Ltd. and its affiliated company Getz Pharma International FZ LLC in an $8 million deal. Getz acquired rights to commercialize Handayuan in Pakistan, the Philippines, Vietnam, Cambodia, Myanmar, Nigeria, Kenya, Sri Lanka, Ukraine, Kazakhstan and Uzbekistan, among others.

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