BioCentury | Oct 20, 2020
Deals

Oct. 19 Quick Takes: Genesis, Genentech in AI drug discovery deal; plus Endo-BioSpecifics, Gemini, Catalyst-Jacobus, ONK, Venclexta

Genesis and Genentech collaborate to identify drug candidates using AIStanford spinout and AI platform company Genesis Therapeutics Inc. entered into a collaboration agreement with the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) to identify drug candidates...
BioCentury | Sep 30, 2020
Product Development

Sept. 29 Quick Takes: Ironwood reduces headcount following Phase III miss; plus Sandoz, Catalyst, Myovant, Orphazyme, Synklino, WHO, BridgeBio, Kurma, Junshi, Arcutis, Genfit-LabCorp and GSK

Ironwood to downsize after Phase III GERD failureIronwood Pharmaceuticals Inc. (NASDAQ:IRWD) said it plans to discontinue development of IW-3718 after the therapy missed the primary endpoint in a Phase III trial to treat refractory gastroesophageal...
BioCentury | Jun 26, 2020
Management Tracks

Saunders joins BridgeBio’s board; plus changes at BioXcel, FibroGen, Storm, Athenex, Seres, Chimerix and Catalyst

Brent Saunders has joined the the board of BridgeBio Pharma Inc. (NASDAQ:BBIO); he was chairman, president and CEO of Allergan plc in 2015-20 until its takeout by AbbVie Inc. (NYSE:ABBV) in May. The genetic diseases...
BioCentury | Feb 20, 2020
Politics, Policy & Law

Pharma execs speak out against 'misuse' of Orphan status as another old therapy sees a price hike

Responding to Belcher Pharmaceuticals' use of the Orphan Drug pathway to support price hikes on an old drug, a group of pharma CEOs have raised concerns in an open letter that this type of behavior...
BioCentury | Feb 19, 2020
Politics, Policy & Law

FDA rebuts Catalyst charge that price drove Ruzurgi approval decision

While FDA officials discussed the price of Firdapse amifampridine phosphate from Catalyst in internal emails, those documents do not demonstrate that price played a part in the agency’s decision to approve a competing product, the...
BioCentury | Feb 13, 2020
Politics, Policy & Law

Catalyzing controversy: FDA emails challenge its claims that price plays no role in approvals

Over 200 pages of emails released as a result of litigation against FDA and HHS challenge FDA’s claims that it does not consider price when making approval decisions. The emails pull back the curtain on...
BioCentury | Sep 14, 2019
Financial News

Sept. 13 Financial Quick Takes: Satsuma prices IPO; plus Catalyst scuttles fund-raising and Imara plans a listing

Satsuma raises $82.5M in NASDAQ listing Migraine company Satsuma Pharmaceuticals Inc. (NASDAQ:STSA) gained $1.90 (13%) to $16.90 after raising $82.5 million in a bumped-up IPO. The company sold 5.5 million shares, upsized from the proposed...
BioCentury | Jun 29, 2019
Finance

All eyes on new modality launches, cancer and rare disease data in 3Q19

While the typical summer lull means fewer catalysts in the third quarter, investors will be keeping a close eye on launches of new modality drugs. Of special interest to multiple buysiders is the launch of...
BioCentury | Jun 12, 2019
Politics & Policy

Catalyst lawsuit challenges FDA's ability to bend the law to lower prices

FDA’s ability to bend the law to create competition for a drug is being challenged in federal court. The case, filed Tuesday by Catalyst against HHS and FDA, will test the agency’s ability to use...
BioCentury | May 7, 2019
Company News

Jacobus snags pediatric approval of rare autoimmune disease drug based on adult efficacy data

With the pediatric approval of Jacobus' Ruzurgi amifampridine to treat Lambert-Eaton myasthenic syndrome (LEMS) based on clinical data in adults, FDA could be signaling a shift towards greater acceptance of pediatric extrapolation. Last year, FDA...
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1 - 10 of 151
BioCentury | Oct 20, 2020
Deals

Oct. 19 Quick Takes: Genesis, Genentech in AI drug discovery deal; plus Endo-BioSpecifics, Gemini, Catalyst-Jacobus, ONK, Venclexta

Genesis and Genentech collaborate to identify drug candidates using AIStanford spinout and AI platform company Genesis Therapeutics Inc. entered into a collaboration agreement with the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) to identify drug candidates...
BioCentury | Sep 30, 2020
Product Development

Sept. 29 Quick Takes: Ironwood reduces headcount following Phase III miss; plus Sandoz, Catalyst, Myovant, Orphazyme, Synklino, WHO, BridgeBio, Kurma, Junshi, Arcutis, Genfit-LabCorp and GSK

Ironwood to downsize after Phase III GERD failureIronwood Pharmaceuticals Inc. (NASDAQ:IRWD) said it plans to discontinue development of IW-3718 after the therapy missed the primary endpoint in a Phase III trial to treat refractory gastroesophageal...
BioCentury | Jun 26, 2020
Management Tracks

Saunders joins BridgeBio’s board; plus changes at BioXcel, FibroGen, Storm, Athenex, Seres, Chimerix and Catalyst

Brent Saunders has joined the the board of BridgeBio Pharma Inc. (NASDAQ:BBIO); he was chairman, president and CEO of Allergan plc in 2015-20 until its takeout by AbbVie Inc. (NYSE:ABBV) in May. The genetic diseases...
BioCentury | Feb 20, 2020
Politics, Policy & Law

Pharma execs speak out against 'misuse' of Orphan status as another old therapy sees a price hike

Responding to Belcher Pharmaceuticals' use of the Orphan Drug pathway to support price hikes on an old drug, a group of pharma CEOs have raised concerns in an open letter that this type of behavior...
BioCentury | Feb 19, 2020
Politics, Policy & Law

FDA rebuts Catalyst charge that price drove Ruzurgi approval decision

While FDA officials discussed the price of Firdapse amifampridine phosphate from Catalyst in internal emails, those documents do not demonstrate that price played a part in the agency’s decision to approve a competing product, the...
BioCentury | Feb 13, 2020
Politics, Policy & Law

Catalyzing controversy: FDA emails challenge its claims that price plays no role in approvals

Over 200 pages of emails released as a result of litigation against FDA and HHS challenge FDA’s claims that it does not consider price when making approval decisions. The emails pull back the curtain on...
BioCentury | Sep 14, 2019
Financial News

Sept. 13 Financial Quick Takes: Satsuma prices IPO; plus Catalyst scuttles fund-raising and Imara plans a listing

Satsuma raises $82.5M in NASDAQ listing Migraine company Satsuma Pharmaceuticals Inc. (NASDAQ:STSA) gained $1.90 (13%) to $16.90 after raising $82.5 million in a bumped-up IPO. The company sold 5.5 million shares, upsized from the proposed...
BioCentury | Jun 29, 2019
Finance

All eyes on new modality launches, cancer and rare disease data in 3Q19

While the typical summer lull means fewer catalysts in the third quarter, investors will be keeping a close eye on launches of new modality drugs. Of special interest to multiple buysiders is the launch of...
BioCentury | Jun 12, 2019
Politics & Policy

Catalyst lawsuit challenges FDA's ability to bend the law to lower prices

FDA’s ability to bend the law to create competition for a drug is being challenged in federal court. The case, filed Tuesday by Catalyst against HHS and FDA, will test the agency’s ability to use...
BioCentury | May 7, 2019
Company News

Jacobus snags pediatric approval of rare autoimmune disease drug based on adult efficacy data

With the pediatric approval of Jacobus' Ruzurgi amifampridine to treat Lambert-Eaton myasthenic syndrome (LEMS) based on clinical data in adults, FDA could be signaling a shift towards greater acceptance of pediatric extrapolation. Last year, FDA...
Items per page:
1 - 10 of 151