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Did the FDA just leave the door cracked open for PTC’s Duchenne drug af­ter re­peat­ed slap­downs?

8 years ago
Pharma

Aim­mune's PhI­II peanut al­ler­gy study wows on the pri­ma­ry end­point, set­ting up FDA pitch -- and shares slide

8 years ago
R&D

Ab­b­Vie steers past the wreck­age, re­serves $224M to kick off once-and-done gene ther­a­py with Voy­ager to fight ...

8 years ago
R&D
Pharma

Roche and Take­da try on Em­u­late’s 'or­gan chip' tech for R&D

8 years ago
R&D
Discovery

Eli Lil­ly shut­ters a failed PhII for rheuma­toid arthri­tis, cloud­ing $690M Han­mi pact

8 years ago
R&D

FDA OK makes As­traZeneca the leader in one new seg­ment of the all-im­por­tant lung can­cer mar­ket

8 years ago
R&D

No­var­tis beefs up its da­ta bank on Cosen­tyx’s durable ef­fect on qual­i­ty of life as well as scalp pso­ri­a­sis

8 years ago
R&D

Roivant Sci­ences in ex­clu­sive joint ven­ture talks with Ar­bu­tus; DBV gets green light to sub­mit peanut al­ler­gy patch

8 years ago
News Briefing

White House: Mer­ck and oth­ers hit by Not­Petya were col­lat­er­al dam­age in Rus­sia’s cy­ber­war on the Ukraine

8 years ago
Pharma

Well, that got awk­ward. Arc­turus fires back at ex-CEO Joe Payne

8 years ago
People

Ex-Ax­o­vant COO Mar­i­on Mc­Court lands at Re­gen­eron; GT Bio­phar­ma el­e­vates Shawn Cross to CEO in ex­ec reshuf­fle

8 years ago
Peer Review

The FDA rais­es hopes for Alzheimer's drugs with a new set of draft rules. But are they go­ing too far?

8 years ago
Bioregnum
Opinion

Tiny Apri­cus’ sur­vival strat­e­gy nixed for now by FDA re­jec­tion of erec­tile dys­func­tion ther­a­py, shares crater

8 years ago
R&D

FDA ad­vi­so­ry group re­jects Paci­ra’s pitch for ex­pand­ed use of pain drug

8 years ago
Pharma

Roche pays $1.9B for Ex-Googlers’ tech start­up Flat­iron Health

8 years ago
Startups
Deals

Ar­a­digm los­es CEO, CMO and CFO fol­low­ing reg­u­la­to­ry dis­as­ter; Omeros shares go up on pos­i­tive re­sults for blood clot ...

8 years ago
News Briefing

Sil­i­con Val­ley celebs chip in­to $250M round for age-fight­ing start­up Celu­lar­i­ty. Pla­cen­ta-based CAR-Ts on the ...

8 years ago
Startups

Biover­a­tiv inks $100M gene ther­a­py deal with Ox­ford Bio­Med­ica

8 years ago
Pharma
Cell/Gene Tx

Pfiz­er, Mer­ck KGaA say their PD-L1 Baven­cio al­so flunked PhI­II in the all-im­por­tant lung can­cer field

8 years ago
R&D

Af­ter a slap­down on Orkam­bi price, Ver­tex is drop­ping French tri­al sites while warn­ing pa­tients on ac­cess

8 years ago
Pharma

Woe­ful Ax­o­vant starts ax­ing staff, but de­part­ing CEO David Hung gets a $2.6M ex­it pack­age/bonus

8 years ago
R&D
Pharma

Cure­Vac to de­vel­op mR­NA-based flu, malar­ia vac­cines with new Gates Foun­da­tion grants

8 years ago
R&D

FDA's Got­tlieb out­lines new goals in bud­get plan, look­ing to spur drug re­views

8 years ago
Pharma

Bio­gen shares tum­ble af­ter key ex­ec notes a change­up to piv­otal ad­u­canum­ab study due to 'vari­abil­i­ty'

8 years ago
R&D
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