Gilead's remdesivir is first drug fully approved by FDA to treat COVID-19. Roche and Atea team up on an investigational direct acting antiviral while Moderna reaches the 30,000-patient enrollment target for its Phase III COVE study of the company's investigational mRNA vaccine. 

Vifor CEO Stefan Schulze tells Scrip that an expanded deal with Korsuva developer Cara Therapeutics means the US biotech will not have to invest in a commercial organization as the Swiss firm will mobilize its well-established sales force to launch the treatment for dialysis patients with CKD-associated pruritus.

Many clinicians doubt that aducanumab can really help slow the decline in Alzheimer’s patients – but  US FDA could offer it the benefit of the doubt.

Positive Phase II data for Aptinyx’s novel NMDA receptor modulator are strong enough to take the product into a pivotal study in this difficult-to-treat area.

Early in 2020, company guidance was that pandemic-related effects would have dissipated in the third quarter. Issues specific to J&J and Roche leave this broad conclusion still up in the air.

Recent moves show Chinese biotech firms are increasingly looking to go global by recruiting world-class development talent, and J&J names new APAC pharma head.

Public Company Edition: Four health care special purpose acquisition vehicles went public and two others announced mergers, but only one biopharma firm priced an IPO during the week of 19-23 October. Replimune’s $250m offering led recent FOPOs.

Ultragenyx enters a competitive and complicated market, but the combination of its manufacturing platform with Solid’s transgene could provide an advantage. 

The rare disease-focused firm will pay $90m up front to acquire Orphan Technologies and its Phase I/II enzyme replacement therapy for homocystinuria. Earnouts up to $427m are possible as well.

Gilead's remdesivir is first drug fully approved by FDA to treat COVID-19. Roche and Atea team up on an investigational direct acting antiviral while Moderna reaches the 30,000-patient enrollment target for its Phase III COVE study of the company's investigational mRNA vaccine. 

Vifor CEO Stefan Schulze tells Scrip that an expanded deal with Korsuva developer Cara Therapeutics means the US biotech will not have to invest in a commercial organization as the Swiss firm will mobilize its well-established sales force to launch the treatment for dialysis patients with CKD-associated pruritus.

Through a licensing-out deal with ORIC for its EGFR/HER2 exon-20 inhibitor, South Korea's Voronoi hopes to gain from its new partner's commercialization experience in NSCLC. The alliance aims to build a potentially best-in-class presence in a competitive landscape.

With Roche's oral spinal muscular atrophy therapy Evrysdi off to a strong start after its recent US launch, Novartis is switching its priorities for rival RNA-splicing drug branaplam and putting it into a Phase IIb trial for Huntington's disease.

Dupixent is already is a big seller in severe asthma in adults and adolescents but Sanofi is looking to expand the label after presenting data showing that it is the only biologic in Phase III trial to have demonstrated improved lung function in children.

Novartis passed up the chance for further development of Kyorin's mocravimod for autoimmune diseases but newly formed Priothera is evaluating the S1P receptor modulator for acute myeloid leukemia patients undergoing hematopoietic stem cell transplantation.

The move into Phase III for giroctocogene fitelparvovec comes on the heels of BioMarin's surprise setback when the FDA demanded more proof of durability of its rival hemophilia A gene therapy Roctavian.

Argenx's efgartigimod, an antibody fragment that blocks FcRn, looks most likely to be the first drug to challenge Alexion's Soliris in the myasthenia gravis market after the company presented more positive data from the ADAPT trial.

The US green light for Alkindi is a big step for the UK biotech in its bid to become a world-leading specialty endocrinology business.

Vifor CEO Stefan Schulze tells Scrip that an expanded deal with Korsuva developer Cara Therapeutics means the US biotech will not have to invest in a commercial organization as the Swiss firm will mobilize its well-established sales force to launch the treatment for dialysis patients with CKD-associated pruritus.

Biopharma executives discussed their strategies for treating chronic diseases during the Cell and Gene Meeting on the Mesa, including R&D and regulatory considerations.

Roche Pharma CEO Bill Anderson is excited about the prospects for REGN-COV2 but with the company and Regeneron possibly producing two million doses per year by the end of Q1 2021, meeting demand worldwide will be an impossible task.

Boehringer Ingelheim and Eli Lilly’s SGLT2 inhibitor Jardiance (empagliflozin) reduces cardiovascular deaths and hospitalizations in certain heart failure patients regardless of whether they have diabetes, and regulatory submissions are expected for the additional indication later this year.

MyoKardia is building up its organization to prepare for commercialization of mavacamten, a potential first-in-class agent for obstructive hypertrophic cardiomyopathy.

The European Commission’s approval of GlaxoSmithKline’s Blenrep is one of the first major fruits of a refocused pipeline and development strategy at the big pharma company.