→ Ten months af­ter Ar­ray showed off the pos­i­tive BEA­CON-CRC da­ta that en­ticed Pfiz­er to write a $11.4 bil­lion buy­out check, the phar­ma gi­ant has of­fi­cial­ly bagged the OK. Braftovi is now ap­proved (in com­bi­na­tion with Er­bitux, or ce­tux­imab) to treat BRAF V600E-mu­tant metasta­t­ic col­orec­tal can­cer. An es­ti­mat­ed 15% of all pa­tients with metasta­t­ic col­orec­tal can­cer har­bor BRAF mu­ta­tions, which rep­re­sent a poor prog­no­sis. In a Phase III tri­al, the tar­get­ed ther­a­py in­duced a me­di­an OS of 8.4 months ver­sus 5.4 months for con­trol (p=0.0003).

→ Por­to­la dis­closed that Bris­tol My­ers Squibb and Pfiz­er are walk­ing away from a pact to de­vel­op and com­mer­cial­ize one of its an­ti-an­ti­co­ag­u­lants in Japan. The col­lab­o­ra­tion was formed in 2016 with $15 mil­lion up­front, be­fore an­dex­anet al­fa got on the US mar­ket as An­dexxa. The drug re­vers­es the blood thin­ning ef­fects of fac­tor Xa in­hibitors, in­clud­ing Bris­tol and Pfiz­er’s Eliquis.

→ Rex­ahn Phar­ma­ceu­ti­cals is scut­tling a clin­i­cal pro­gram match­ing their drug RX-5902 with Mer­ck’s an­ti-PD1 star Keytru­da in metasta­t­ic triple neg­a­tive breast can­cer. The two com­pa­nies an­nounced the al­liance back in 2018, as check­point com­bos be­came one of the most pop­u­lar pacts in the in­dus­try. Rex­ahn an­nounced the ter­mi­na­tion of the mid-stage tri­al in an SEC fil­ing.

→ Shares of En­gle­wood, CO-based Viveve Med­ical took an­oth­er tum­ble Thurs­day morn­ing af­ter the biotech ac­knowl­edged that its tech for im­prov­ing sex­u­al func­tion in women fol­low­ing vagi­nal births had flopped. Their ther­a­peu­tic ap­proach demon­strat­ed the same kind of per­for­mance as a sham, send­ing shares $VIVE down 28%. The fail­ure, which drove shares deep­er in­to pen­ny stock ter­ri­to­ry, left the com­pa­ny re­view­ing its “strate­gic op­tions.”

Seattle-based Presage Biosciences, which approaches drug development through its microdosing platform, has some new partnerships and cash to come with them.

Presage closed a $13 million financing round Tuesday, aiming to expand its network of clinical trial sites and advance development of its microdosing injection devices. They also closed partnership deals with Merck and Maverick Therapeutics.

The financing included $7 million from new investors, including the LabCorp Venture Fund, Bristol Myers Squibb, and InHarv Partners. An additional $6 million convertible note from Takeda Ventures will convert to equity.

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

One of Europe’s most high-profile biopharma investors is getting $540 million to invest in new crossover deals for late-stage companies.

The Paris-based VC says the fresh Sofinnova Crossover Fund raise positions them as the “largest crossover investor in Europe dedicated to late-stage biopharma and medtech investments.”

They got a leg up in France after winning a special “Tibi” designation from the French government, giving them access to a pool of €6 billion that helped them gain an edge with institutional investors. Since they were founded close to 50 years ago, the venture group has backed more than 500 companies and currently has more than €2 billion under management.