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John Thero, Amarin CEO (Christopher Goodney/Bloomberg via Getty Images)

Amarin los­es patent ap­peal and their brief grip on a car­dio­vas­cu­lar, fish oil em­pire

Amarin’s briefly-held fish oil empire has slipped from its grasp, and now appears gone for good.

A US federal appeals court refused on Thursday to overturn a March ruling that stripped the Irish drugmaker of its patents on the fish oil-based heart drug Vascepa, opening the door for generic alternatives to hit the market. The ruling means that Amarin’s chance of turning an expanded approval from last December into blockbuster revenues has essentially vanished.

Michelle McMurry-Heath, BIO CEO (BIO)

BIO and a string of CEOs is­sue a call for FDA in­de­pen­dence and against sci­ence-by-press-re­lease

It appears to be open letter week in biotech.

On Sunday, Scripps Research’s Eric Topol penned a scathing letter in Medscape calling for FDA commissioner Stephen Hahn to resign after a series of alleged missteps and political concessions.  And today, in a carefully-worded piece, the head of BIO and eight well-known biotech CEOs issued a call for the FDA’s independence and for biotechs — with the world spotlight on them — to be on their best behavior.

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Bris­tol My­ers snares an­oth­er ap­proval from the old Cel­gene pipeline, nab­bing an over­looked OK

Bristol Myers Squibb has gotten another approval from the old Celgene pipeline yesterday, this time for a once low-profile compound.

The FDA green-lighted Onureg, an oral drug previously known as CC-486. It’s chemically known as azacitidine — the same compound that in its IV form, branded as Vidaza, has long been used to treat acute myeloid leukemia and myelodysplastic syndromes. For Bristol Myers, it marks the second major approval since the Celgene merger was completed, after the multiple sclerosis drug Zeposia was OK’d earlier this year.

Mark Pruzanski, Intercept CEO (GlobeNewswire via YouTube)

Spurned by the FDA, In­ter­cept brings out the bud­get axe and chops 170 jobs

The unexpected CRL that landed at Intercept Pharmaceuticals $ICPT 2 months ago is costing the biotech dearly.

In an SEC filing Tuesday, the company said that it is slashing 25% of its workforce, or a total of 170 jobs. The move — with the bulk of the cuts coming in Q3 — will cost the company $18 million, Intercept noted, adding that it’s required to conserve cash as they go on trying to get an approval for NASH.

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Richard Gonzalez, AbbVie CEO (AP Images)

House Over­sight Com­mit­tee sub­poe­nas Ab­b­Vie over 'woe­ful­ly in­ad­e­quate' doc­u­ment pro­duc­tion in price-goug­ing probe

Congress is turning up the heat on AbbVie $ABBV over its pricing policies.

The House Committee on Oversight and Reform is planning to subpoena the biopharma as part of a 2019 probe into the alleged price-gouging of Humira and Imbruvica, according to a memo released Monday. The move comes after the late Elijah Cummings, who chaired the committee, opened the investigation into a dozen drugmakers over 18 months ago and AbbVie did not provide lawmakers with requested documents.

In the foot­steps of As­traZeneca, No­var­tis com­mits to car­bon-neu­tral sup­ply chain by 2030

Following in AstraZeneca’s carbon-reduced footsteps, Novartis announced new sustainability targets on Tuesday, which include plans to neutralize supply chain emissions in the next 10 years.

The Swiss pharma aims to be carbon-neutral in its own operations by 2025, and across its supply chain by 2030. To get there, it says it will reduce absolute emissions by 35% across its value chain, and follow a “dual strategy” to decrease energy and fuel consumption, improve efficiency and adopt renewable energy sources. It audited all major sites for potential improvements.

Te­va charged — again — for al­leged role in fix­ing gener­ic drug prices, this time by the De­part­ment of Jus­tice

The docket keeps piling up for Teva.

Late Tuesday, the Justice Department became the latest in a long string of prosecutors to accuse the Israeli drugmaker of malfeasance, charging the company with three counts of conspiring to fix generic drug prices. These new allegations come just a week after Teva $TEVA was sued by New York over its role in the opioid epidemic and by federal prosecutors over its purported scheme to defraud Medicare.

The 105 by Breakthrough; Payette architecture firm

That new biotech com­pound Arie Bellde­grun & Co. have been build­ing in Sea­port? It turns out one fast-grow­ing de­vel­op­er took the whole thing

When Kite founder Arie Belldegrun laid out his vision for the new biotech building he and son Dan were building with Tishman Speyer in Seaport, he had an idea for a club-like environment that would bring together scientists and entrepreneurs interested in building drugs and companies.

But then the market took control.

Instead of multiple tenants, Breakthrough Properties got one growing biotech to take all 263,500 square feet of space at The 105.

Sev­en PD-(L)1 play­ers could be vy­ing for a place on Chi­na's drug re­im­burse­ment list. How far will they go?

New updates to the process of assembling China’s latest National Drug Reimbursement List could mean that seven additional PD-(L)1 drugs will be covered by government-sponsored insurance schemes — but likely not without significant discounts.

Developers of therapies approved by the National Medical Products Administration before August 17 will be eligible to apply for inclusion on the list. The deadline also applies to any drug that scored new indications.

Artist's rendering of the Bristol Myers Squibb campus in Cambridge, MA (BMS)

Bris­tol My­ers joins the lab rush in Cam­bridge with plans to con­sol­i­date R&D ops in a biotech cam­pus now un­der con­struc­tion

Bristol Myers Squibb is following Sanofi on the big trek to a new biotech campus now being built in the booming Cambridge, MA biopharma R&D hub.

The pharma giant has inked a 360,000-square-foot lease at Cambridge Crossing, where the dirt is flying on a sprawling 43-acre life sciences hub on the city line between Cambridge and Somerville.

Bristol Myers plans to consolidate its staff in the area, which includes a location at 100 Binney Street, with plans to move into a new building at 250 Water Street in 2023.

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