The first close of a series C financing should enable InRhythm to enter Phase III as an inhalable anti-arrhythmic for paroxysmal atrial fibrillation in a medically supervised setting.

Drugs that have failed in clinical studies often come back for another go, making the same mistakes for a new cohort of investors who missed the first failure. The global pandemic is also enabling this for once- or twice-failed drugs.

Analysts considered the Phase III GALACTIC-HF study of omecamtiv mecarbil a failure but some anticipated that detailed data to be presented next month could at least partially redeem the drug.

Paying $13.1bn for MyoKardia and its potential first-in-class HCM drug, BMS sees a blockbuster sales opportunity that it will grow gradually. MyoKardia team will be absorbed into BMS, Caforio says.

For a biotech launching its first product the pandemic has compounded the usual pressures of a competitive indication against deeper-pocketed competition.

The UK's Silence Therapeutics is moving its candidate products into early clinical studies in cardiovascular diseases and improving its visibility with a NASDAQ listing.

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.

Positive clinical results pave path forward for Japanese firm’s potential istradefylline successor.

Biogen lowered revenue guidance for the year by $600m due to Tecfidera generics and said it could consider broader cost cuts in 2021 depending on the outcome of aducanumab at the US FDA.

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.

Deal Snapshot: Lilly bets $135m on biotech’s preclinical SARM1 inhibitor program, seeing potential in peripheral neuropathy and possibly some bigger targets in neurology like MS and ALS.

Palforzia will almost certainly be the first treatment to get the green light for peanut allergy in Europe and its new owner will be hoping for a more successful launch than has been seen in the US.

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.

Galapagos and Gilead's JAK inhibitor has been approved for rheumatoid arthritis in the second and third biggest pharma markets, softening the blow somewhat of rejection from the US FDA in the biggest market last month.

Tildrakizumab debuts in Japan, marking a key milestone for Sun Pharma, though heavyweight competitors including same class rival Skyrizi are already available on the market there.

The coronavirus pandemic hurt the German group's healthcare division but helped the contract development and manufacturing activities of Merck's life sciences business.

It has been a tough couple of months for the Belgian biotech since the FDA surprisingly rebuffed its JAK inhibitor filgotinib but promising data on the oral autotaxin inhibitor ziritaxestat helped soften the blow and drive up Galapagos stock.

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. 

From efficacy endpoints to patient warehousing, US FDA advisors weigh in on vaccine development and regulatory review.

Pfizer CEO says that an EUA request for its COVID-19 vaccine is unlikely before late November. Analyst calls Pfizer’s development pace an encouraging sign it could be a more nimble company.

Plus Sanofi and Translate Bio release preclinical data from their COVID-19 vaccine candidate, another entrant to the now crowded mRNA vaccine field.

The US FDA approved the first antibody cocktail for ebolavirus infection, supporting a supply contract with BARDA. The development experience informed Regeneron's work in COVID-19.

With a candidate COVID-19 therapy in clinical development, the UK’s Synairgen has raised $101m on the UK’s AIM to support clinical studies and manufacturing plans.

Orchard Therapeutics is on the cusp of the first approval for its ex vivo gene therapy, Libmeldy, for metachromatic leukodystrophy.

Takeda's global deal for one of US RNAi specialist's lead assets follows recent promising clinical results in serious disorder with no current therapeutic options.

With multiple South Korean INDs to begin Phase III trials with its SGLT-2 inhibitor enavogliflozin, Daewoong is aiming to speed domestic and global development of the potentially best-in-class drug for type 2 diabetes.

Centaur-CytoTools introduces novel topical treatment for diabetic foot ulcers in India, for which they see limited direct competition and hope to change the way the difficult-to-treat diabetes complication is managed. Phase III studies are ongoing in Europe.

Join us for a quick audio roundup of five useful things to know from Scrip's recent coverage of developments in the global biopharmaceutical industry.

NASH has become a major therapeutic focus for pharma firms in South Korea, where companies are speeding up development and expanding their pipelines after Yuhan’s sizable global license deals last year.

Nuvation started in 2018 and raised a $275m series A round in 2019. Now it is merging with the EcoR1 Capital-sponsored SPAC Panacea Acquisition Corp. and raising $500m in equity capital.

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.

Join us for a brief audio roundup of the major developments in the international biopharma industry over the past week, as covered by Scrip's global team.

Gilead/Kite’s second CAR-T product is given the go-ahead for approval by the CHMP for mantle cell lymphoma.

The development of first-in-class anticancers that activate protein phosphatase 2A is the aim of the Helsinki-headquartered Rappta Therapeutics. It has just raised €9m in a series A involving top-tier biotech VCs to move promising candidates towards the clinic.

Positive top-line data from a second pivotal trial cohort are set to support regulatory filings for the ADC in patients whose cancer has progressed after immunotherapy but are ineligible for cisplatin.

Glenmark and Sun Pharma introduce nintedanib generics in India at a fraction of the innovator product’s price, vying for a share of the IPF market where pirfenidone currently holds sway.

The Phase I trial of IONIS-ENAC-2.5Rx for cystic fibrosis represents the first time an antisense medicine delivered directly to the lung has shown a significant reduction in ENaC messenger RNA levels.

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.

While Vertex appears to have the cystic fibrosis market covered with its CFTR modulators, Enterprise has been exploring another channel, TMEM16A, in the hope of developing compounds that could possibly be used by everybody with the lethal genetic disease.

The French drugmaker is looking to consolidate its dominance of the Pompe disease area by filing its successor to Myozyme in Europe, but Amicus Therapeutics' potential rival AT-GAA is on the horizon.

It has been a tough couple of months for the Belgian biotech since the FDA surprisingly rebuffed its JAK inhibitor filgotinib but promising data on the oral autotaxin inhibitor ziritaxestat helped soften the blow and drive up Galapagos stock.