BioCentury | May 21, 2019
Clinical News

BioCryst makes case for oral HAE therapy even as Phase III data disappoint investors

Despite reporting Phase III efficacy data for its oral hereditary angioedema therapy that fell short of marketed injectable therapies to prevent HAE attacks, BioCryst believes the demand for an oral option will enable BCX7353 to...
BioCentury | Jan 25, 2019
Finance

Venrock spreads HAE bets

Venrock is broadening its portfolio of oral hereditary angioedema therapy investments by leading a $23 million series B round that will allow Attune Pharmaceuticals to move its lead plasma kallikrein (KLKB1) inhibitor into Phase II...
BioCentury | Jan 12, 2019
Finance

We all fall down

After an exuberant third quarter that put biotech indexes near their 2015 highs, all market cap tiers fell in 4Q18, eliminating the first nine month’s gains and losing $291.2 billion in aggregate value. Median losses...
BioCentury | Jan 5, 2019
Finance

Ready to launch

The proposed $74 billion takeout of Celgene Corp. by Bristol-Myers Squibb Co. will not shift buysider attention away from upcoming and maturing drug launches heading into 2019, with plenty to track following a record year...
BioCentury | Oct 26, 2018
Clinical News

CHMP backs Takhzyro, Dengue vaccine, biosimilar Herceptin

EMA’s CHMP on Oct. 19 recommended several approvals, including hereditary angioedema (HAE) mAb Takhzyro lanadelumab, dengue vaccine Dengvaxia and Herceptin trastuzumab biosimilar Ogivri. CHMP backed Takhzyro from Shire plc (LSE:SHP; NASDAQ:SHPG) to prevent recurrent attacks...
BioCentury | Oct 19, 2018
Company News

CHMP backs Takhzyro, Dengue vaccine, biosimilar Herceptin

EMA’s CHMP recommended several approvals Friday, including hereditary angioedema (HAE) mAb Takhzyro lanadelumab, dengue vaccine Dengvaxia and Herceptin trastuzumab biosimilar Ogivri. CHMP backed Takhzyro from Shire plc (LSE:SHP; NASDAQ:SHPG) to prevent recurrent attacks of HAE....
BioCentury | Oct 6, 2018
Finance

Large cap comeback

The biotech sector continued to be a stock pickers’ market through 3Q18 as there was a near even split between global biotech stocks that gained and lost value in the quarter. While 1H18 saw investors...
BioCentury | Sep 21, 2018
Clinical News

FDA wants extra trial for Pharming's Ruconest as HAE Prophylactic

Pharming Group N.V. (Euronext:PHARM) said FDA requested another clinical trial of Ruconest conestat alfa as a prophylactic for hereditary angioedema in a complete response letter for an sBLA in the indication. Pharming, which fell €0.20...
BioCentury | Sep 19, 2018
Company News

FDA wants extra trial for Pharming's Ruconest as HAE prophylactic

Pharming Group N.V. (Euronext:PHARM) said FDA requested another clinical trial of Ruconest conestat alfa as a prophylactic for hereditary angioedema in a complete response letter for an sBLA in the indication. Pharming, which fell €0.20...
BioCentury | Aug 31, 2018
Clinical News

FDA approves Shire's Takhzyro, first mAb to prevent HAE

Shire plc (LSE:SHP; NASDAQ:SHPG) said FDA approved Takhzyro lanadelumab-flyo to prevent attacks of hereditary angioedema in patients ages 12 and older. The company said Takhzyro is the first mAb approved in the U.S. to prevent...
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