FDA OKs Blueprint’s pralsetinib for certain type of lung cancer

Under accelerated review status, the FDA approves Blueprint Medicine’s (NASDAQ:BPMC) Gavreto (pralsetinib) for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC).

The company will co-commercialize the once-daily RET inhibitor in the U.S. with Roche’s Genentech. Market launch will commence within one week.

Roche will commercialize ex-U.S. excluding Greater China.

Management will host a webcast this morning at 8:00 am ET to discuss the nod.

https://seekingalpha.com/news/3611972-fda-oks-blueprints-pralsetinib-for-certain-type-of-lung-cancer

FDA OKs Roche BK virus test for automated systems

The FDA grants 510(k) clearance to Roche’s (OTCQX:RHHBY) quantitative BK virus molecular test for its automated cobas 6800 and 8800 lab systems.

BK is a polyomavirus that can cause severe transplant-associated complications.

https://seekingalpha.com/news/3611986-fda-oks-roche-bk-virus-test-for-automated-systems

Mylan nabs Aspen Pharmacare’s European thrombosis biz for €641.9M

Mylan (NASDAQ:MYL) has agreed to acquire Aspen Pharmacare Holdings Limited’s thrombosis business in Europe for €641.9M to be paid in two tranches, €263.2M upfront and €378.7M on June 25, 2021.

Leading coagulants Arixtra, Fraxiparine, Mono-Embolex and Orgaran generated ~€231M in sales during the 12-month period ended June 30.

Aspen will continue to manufacture and supply product.

The transaction, expected to be finalized next quarter, should be immediately accretive to Viatris upon the completion of the Upjohn merger, also expected to be completed next quarter.

The deal should not impact its 2020 target of ~$1B of debt repayments or Viatris’ debt repayment and target leverage commitments.

https://seekingalpha.com/news/3611973-mylan-scoops-up-aspen-pharmacares-european-thrombosis-business-for-641_9m

UK health service expects AstraZeneca’s COVID-19 vaccine in early 2021

September 8, 2020

U.K. health secretary Matt Hancock on Monday said a COVID-19 vaccine would “most likely” be available in the first few months of 2021.

“We have got 30 million doses already contracted with AstraZeneca (NYSE:AZN), in fact they are starting to manufacture those doses already, ahead of approval, so that should approval come through, then we are ready to roll out,” Hancock told national news radio station LBC.

AZN has already begun final-stage trial of COVID-19 vaccine in U.S.

https://seekingalpha.com/news/3611970-uk-health-service-expects-astrazenecas-covidminus-19-vaccine-in-early-2021

Albireo up ahead of late-stage odevixibat data readout

Thinly traded micro cap Albireo Pharma (NASDAQ:ALBO) perks up 10% premarket on light volume ahead of this morning’s conference call (8:30 am ET) to discuss topline results from a Phase 3 clinical trial, PEDFIC 1, evaluating lead candidate odevixibat in patients with a rare inherited disorder called progressive familial intrahepatic cholestasis (PFIC) in which liver cells are unable to secrete bile due to mutations in a gene the encodes a protein that plays a key role in bile acid homeostasis (stable equilibrium).

The company announced Phase 2 results in June 2019 that showed treatment with odevixibat reduced serum bile acid levels as much as 92%.

Odevixibat selectively inhibits a protein called the ileal bile acid transporter (IBAT), which, as the name implies, plays a key role in transporting bile from the liver to the colon.

https://seekingalpha.com/news/3611977-albireo-up-10-ahead-of-late-stage-odevixibat-data-readout

Takeda divests certain non-core assets to Cheplapharm for $562M

Continuing to follow through on its previously announced strategic focus on five key business areas, Takeda Pharmaceutical Company (NYSE:TAK) has agreed to sell a lineup of non-core prescription medicines marketed predominantly in Europe and Canada to German drug firm Cheplapharm for ~$562M.

The portfolio, which generated ~$260M in net sales in fiscal 2019, includes cardiovascular/metabolic and anti-inflammatory products along with Calcium.

The transaction should close by the end of Q1 2021.

https://seekingalpha.com/news/3611980-takeda-divests-certain-non-core-assets-to-cheplapharm-for-562m

Dr. Reddy’s launches generic Faslodex Injection in U.S.

Dr. Reddy’s Laboratories (NYSE:RDY) announces the launch of Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per Single-dose Syringe, a therapeutic equivalent generic version of AstraZeneca’s (NYSE:AZN) FDA approved Faslodex (fulvestrant) Injection, 250 mg/5 mL (50 mg/mL).

Per IQVIA, the U.S. market is ~$­­­­­407M.

https://seekingalpha.com/news/3611953-dr-reddys-launches-generic-faslodex-injection-in-u-s