Competition intensifies in novel anemia therapy space in Japan with first filing globally for Akebia/Mitsubishi Tanabe’s contender vadadustat, which could see its first launch worldwide in the country.

Emerging Company Profile: Using IP licensed from Yale, Kleo is betting it can complement or replace existing immuno-oncology drugs, specifically Darzalex. In partnership with PeptiDream, it just unveiled its first candidate for clinical development.

Despite increasing competition, Celltrion has leapt into China's growing biosimilar market through a joint venture with Nan Fung, and another draw could lie in the biologics contract manufacturing potential in the country’s developing Greater Bay Area.

An Indian court has frowned upon Novartis and opponent Natco for seemingly delaying proceedings before the Controller General of Patents in a case concerning the Swiss firm’s anticancer ceritinib. The patent office wasn’t spared either, with the court asking the Controller to ensure that once orders are reserved, a time period is prescribed for delivering the decision.

The first generic versions of Pfizer's blockbuster pain medicine pregabalin have launched in the US. Pfizer has guided investors the company will return to growth in 2020 after cycling through the loss.

Investors during Roche’s second-quarter update on Thursday will look for updates on coming biosimilar competition, promising pipeline assets, and the delayed Spark Therapeutics acquisition.

Shares of Korea's Medytox fell on suspicions that it supplied botulinum toxin to local hospitals before the product's approval in 2006. The concerns add to other manufacturing issues that have been denied by the company, which pointed to a rival as the possible source amid an ongoing legal battle over the strain used in the product.

Biopharma companies are reluctant to rely on real-world evidence trials, but while uncertainty remains about how these novel studies will be accepted, US and other regulators are encouraging drug developers to take a chance – and some have taken on the challenge.

Viren Mehta of Mehta Partners LLC mulls the potential of blockchain, the rapidly evolving IT resource that secures every step in a business action.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

As it waits for a US FDA decision on its antibiotic cefiderocol, the Japanese company has handed over the rights to a Pseudomonas aeruginosa therapy that will go into the clinic next year.

Bayer’s VC LEAPS program invests in a second new biotech this month through its participation in the series A funding round for new immuno-oncology biotech Pyxis Oncology.