Last week in biopharma-earnings reports, drug pricing, a new GENE CEO and more

January 27, 2019

Tuesday

This was a short work week for many due to MLK Day on Monday, but Tuesday started off Q4 earnings report time and JNJ was up first with a beat on earnings expectations. However, there are definite signals that sales are slowing in 2019. In other company news, Takeda is reportedly thinking about selling off its emerging markets products. Roche’s management is reported as saying that it is not currently interested in mega deals, but would be open to smaller M&A action.

In clinical trial news, Aurinia’s dry eye drug falls short in improving tolerability versus Allergan’s Restasis, but beats on efficacy. And Sorrento Therapeutic’s injection shows fast, durable pain relief in an early trial for osteoarthritis of the knee.

Also, this Biospace piece gives a thorough analysis of the current companies developing in the NASH treatment space, which is a market that is likely to explode soon.

Wednesday

Addressing the price of prescription drugs will be a priority for the Senate Finance Committee, Chairman Sen. Chuck Grassley has announced Tuesday. Grassley said in a statement he plans to hold a series of hearings "scrutinizing prescription drug pricing and considering policy and oversight solutions to lower costs for American patients.” He said the first hearing, to be held on Jan. 29, will include testimony from economists and a patient advocate.

In company news, GSK has completed the $5.1 billion acquisition of Tesaro, which will further its oncology program. Abbott Labs did not meet expectations for Q4 earnings, and microbiome test company uBiome is reportedly laying off a sizable number of employees to focus more on “partnerships and drugs.”

Elsewhere, the FDA has finalized its guidance on labeling for accelerated drug approvals, and Silicon Valley startup One Health hopes to bring precision medicine to the treatment of cancer in dogs.

Thursday

Genentech has announced a new CEO, to assume the role March 1 2019. Alexander Hardy is currently an executive with Roche in Basel, and will be moving to San Francisco to assume the Genentech head post. In other company-related news - JNJ’s dismal 2019 outlook may indicate what’s in store this year for other Big Pharma firms. And Bluebird Bio has outlined a timeline of what to expect for the company in the next five years.

In a big blow to its oncology program, Bristol-Myers is pulling its Opdivo/Yervoy combo in NSCLC. And Advaxis was also dealt a blow when the FDA put a partial clinical hold on its cervical cancer studies.

Elsewhere, Basilea is entering a urothelial cancer study with Roche, and Vertex’s gene editing collaboration with Merck KGaA is coming to fruition.

Friday

After last week’s announcement the that Lilly’s cancer drug Lartruvo did not help patients live longer in a confirmatory study, both the FDA and the EMA are calling for new prescriptions for the drug to be halted.

In other news, the FDA may have a plan for continuing drug approvals should the government shutdown drag on, and Novartis is warning the UK about the need to build large drug stockpiles ahead of Brexit.

In company-related news, AbbVie’s 4th quarter earnings were disappointing, in part due to European Humira biosimilar challenges. And Medtronic is going to acquire cardiac ablation tech developer Epix Therapeutics. 


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