Some top-selling cancer drugs from international and local pharmas took an average 56.7% discount to get onto China's insurance coverage list. An FDA expert panel unanimously backed Celltrion's Rituxan biosimilar, making a final FDA nod look more likely than not. Building on their Abilify MyCite partnership, Otsuka and Proteus have extended their digital pill pact for another five years.
1. Novartis, Pfizer, AZ and more hand China 50%-plus cancer drug discounts
China has wrapped up its latest national insurance drug negotiations, bagging discounts averaging 56.7% on 17 cancer drugs from global and domestic companies. Novartis secured four deals, the most among the companies involved, followed by Pfizer’s three. AstraZeneca’s 71% discount for Tagrisso ranked as the biggest. Lung cancer became the most sought-after area, with all together five drugs listed.
2. FDA panel unanimously backs Celltrion's Rituxan biosimilar
FDA reviewers endorse Celltrion's Rituxan biosimilar ahead of panel vote
Celltrion’s biosimilar to Roche’s blockbuster Rituxan is getting its second chance at the FDA after manufacturing deficiencies sent its first attempt south. A review document from FDA staffers said it showed no “clinically meaningful differences” from the Roche drug, and then, on Wednesday, an FDA advisory panel unanimously endorsed its approval. Next up, a potential approval that now looks likely for the biosim maker.
3. Otsuka and Proteus sign 5-year, $88M digital pill partnership
Last year, Otuska and Proteus’ Abilify MyCite became the first “smart pill” that can digitally track patient’s adherence. Now, the two companies have expanded their partnership to other meds. Otsuka has given Proteus $88 million to advance some new digital medicines focused on mental health, as the Japanese pharma deploys a strategy to step up its portfolio with value-added products.
4. Actually, it's just one site: FDA corrects previous word on embattled valsartan maker's ban
Litigation teaches Chinese valsartan maker the downside of U.S. market
The FDA made a confusing mistake when it said it’s banning “all” active ingredients made by Zhejiang Huahai Pharmaceutical, plus finished drugs made using its APIs. In fact, the import alert only applies to the Chinese firm’s Chuannan site in China. Besides the ban, Huahai also faces multiple lawsuits over tainted valsartan in the U.S.; "gross negligence" figures among the allegations.
5. Takeda spinoff GenAhead Bio inks partnership with ERS Genomics on CRISPR/Cas9 patents
Eyeing a dominant genome-editing service, Takeda spinoff GenAhead has nonexclusively licensed Irish firm ERS Genomics’ CRISPR-Cas9 patents, which came from Emmanuelle Charpentier, a co-inventor of the technology with University of California’s Jennifer Doudna. A federal appeals court recently ruled that CRISPR patents owned by the Broad Institute and the university do not “interfere” with each other.
6. Quest to sell its India diagnostics arm to Strand Life Sciences
Quest Diagnostics has agreed to sell off its India medical diagnostics business to Bangalore-based Strand Life Sciences, citing a changing business model. Included on the sale list is a 65,000-square-foot lab that will be added to Strand’s network of 24 labs across India.