00:47 , Jun 29, 2019 |  BioCentury  |  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...
20:28 , Jun 12, 2019 |  BC Extra  |  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...
22:51 , May 7, 2019 |  BC Extra  |  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...
00:23 , Jan 12, 2019 |  BioCentury  |  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...
02:49 , Jan 5, 2019 |  BioCentury  |  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...
00:04 , Dec 15, 2018 |  BC Extra  |  Politics & Policy

Firdapse re-catalyzes pricing debate

A decision by Catalyst Pharmaceuticals Inc. (NASDAQ:CPRX) to charge $375,000 a year for Firdapse amifampridine phosphate, a drug that was previously available for free, has re-catalyzed debate about the U.S. government’s drug exclusivity policies. The...
18:23 , Nov 30, 2018 |  BC Week In Review  |  Clinical News

Catalyst's Firdapse becomes first FDA-approved drug for rare autoimmune disease

FDA approved a resubmitted NDA for Firdapse amifampridine phosphate from Catalyst Pharmaceuticals Inc. (NASDAQ:CPRX). The agency said Firdapse is the first drug approved to treat Lambert-Eaton myasthenic syndrome (LEMS). In 2016, FDA issued a refusal-to-file...
22:04 , Nov 29, 2018 |  BC Extra  |  Company News

Catalyst's Firdapse becomes first FDA-approved drug for rare autoimmune disease

FDA approved a resubmitted NDA for Firdapse amifampridine phosphate from Catalyst Pharmaceuticals Inc. (NASDAQ:CPRX). The agency said Firdapse is the first drug approved to treat Lambert-Eaton myasthenic syndrome (LEMS). In 2016, FDA issued a refusal-to-file...
00:48 , Oct 6, 2018 |  BioCentury  |  Finance

Seeking validation

The final stretch of the year offers clinical catalysts and early launch data that could validate investments in hot immuno-oncology targets and large untapped markets. Late-stage readouts from Vertex Pharmaceuticals Inc. in cystic fibrosis and...
17:55 , Jun 1, 2018 |  BC Week In Review  |  Clinical News

Catalyst's Firdapse gets Priority Review in U.S.

Catalyst Pharmaceuticals Inc. (NASDAQ:CPRX) said FDA accepted and granted Priority Review to a resubmitted NDA for Firdapse amifampridine phosphate to treat Lambert-Eaton myasthenic syndrome (LEMS). The PDUFA date is Nov. 28. In 2016, the agency...