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Latest Drug Approvals NewsRSS

22:30 EDT 23rd September 2018 | BioPortfolio

GS $LOXO expected approval of larotrectinib and emerging regulatory path for -292 set Loxo on a path to meaningful end market sales. However, the collaboration partnership with Bayer puts a constraint on revenue and profits and could be a potential hurdle

GS $LOXO expected approval of larotrectinib and emerging regulatory path for -292 set Loxo on a path to meaningful end market sales. However, the collaboration partnership with Bayer puts a constraint on revenue and profits and could be a potential hurdle for an acquirer.

Couple sell side reports I see have $RVNC with EPS of 3 bucks by 2022 - $RVNC very derisked phase 3 asset awaiting approval. Undervalued GS roadshow last 2 days on $RVNCpic.twitter.com/4YlUNrUbG8

Couple sell side reports I see have $RVNC with EPS of 3 bucks by 2022 - $RVNC very derisked phase 3 asset awaiting approval. Undervalued GS roadshow last 2 days on $RVNC pic.twitter.com/4YlUNrUbG8

LR $OBSV look for mGTto provide greater regulatory clarity on requirements for approval in both US&EU in 3Q18.risk-reward is skewed to upside ahead of upcoming catalysts in 2H18;look for live birth rate data from IMPLANT 2 in 4Q18, which if positive shoul

LR $OBSV look for mGTto provide greater regulatory clarity on requirements for approval in both US&EU in 3Q18.risk-reward is skewed to upside ahead of upcoming catalysts in 2H18;look for live birth rate data from IMPLANT 2 in 4Q18, which if positive should go a long way in improv

Boston Scientific Eluvia Drug-Eluting Stent Demonstrates Superior Results In IMPERIAL Trial

First head-to-head trial assesses effectiveness of sustained drug release in interventional treatment for patients with blockages in femoropopliteal arteries SAN DIEGO and MARLBOROUGH, Mass., Sept. 22, 2018 /PRNewswire/ -- Today, Boston Scientific (NYSE: BSX) announced positive 12-month data from the IMPERIAL trial, the first head-to-head drug-eluting stent trial in the superficial femoral arter...

potentially demonstrates drug’s potency.Further,MOA of thyroid-#agonist in treating NAFLD is further strengthened with two active programs in development. recognizing potential first mover advantage,potential best-in- class drug frequently take great

potentially demonstrates drug’s potency.Further,MOA of thyroid- #agonist in treating NAFLD is further strengthened with two active programs in development. recognizing potential first mover advantage,potential best-in- class drug frequently take greater market share longer term.

STAT Plus: Patient advocates object to "evergreening" a drug patent to keep making money. Now an insurer is suing a drug maker over the practice. https://buff.ly/2Nsb8au 

STAT Plus: Patient advocates object to "evergreening" a drug patent to keep making money. Now an insurer is suing a drug maker over the practice. https://buff.ly/2Nsb8au 

EU Panel Backs Venetoclax/Rituximab Combo in Relapsed/Refractory CLL

The European Medicines Agency’s Committee for Medicinal Products for Human Use is supporting the approval of venetoclax in combination with rituximab for patients with chronic lymphocytic leukemia who have received at least 1 previous therapy.

CHMP Issues Positive Opinion on Pegfilgrastim Biosimilar

The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of filgrastim-sndz, a biosimilar for pegfilgrastim.

Drug shortages may add $230 million to annual U.S. drug costs https://reut.rs/2I2TLHj 

Drug shortages may add $230 million to annual U.S. drug costs https://reut.rs/2I2TLHj 

EU Panel Grants Positive Opinion to Brigatinib for ALK+ NSCLC

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended full approval of brigatinib (Alunbrig) as a treatment for patients with advanced ALK-positive non–small cell lung cancer who are previously treated with crizotinib (Xalkori).

STAT Plus: A European health insurer sues AstraZeneca over a patent maneuver

Patient advocates object to "evergreening" a drug patent to keep making money. Now an insurer is suing a drug maker over the practice.

Shire Receives Approval of FIRAZYR (icatibant injection) for the Treatment of Hereditary Angioedema (HAE) Attacks in Japan

Shire (LSE:SHP,NASDAQ:SHPG) the leading global biotechnology company focused on rare diseases, announced that the Ministry of Health, Labour and Welfare (MHLW) in Japan has granted manufacturing and marketing authorisation for FIRAZYR (icatibant injection), for the acute treatment of hereditary angioedema (HAE) attacks in adult patients with HAE. As quoted in the press release: HAE is a … C...

$SGEN #Takeda ADCETRIS® (Brentuximab Vedotin) Approval in Japan for Frontline Hodgkin Lymphoma https://www.businesswire.com/news/home/20180921005364/en/Seattle-Genetics-Announces-ADCETRIS%C2%AE-Brentuximab-Vedotin-Approval …

$SGEN #Takeda ADCETRIS® (Brentuximab Vedotin) Approval in Japan for Frontline Hodgkin Lymphoma https://www.businesswire.com/news/home/20180921005364/en/Seattle-Genetics-Announces-ADCETRIS%C2%AE-Brentuximab-Vedotin-Approval …

Tetraphase Pharmaceuticals Announces Adoption of Commission Decision Granting Marketing Authorisation Approval in the European Union for XERAVA

Tetraphase Pharmaceuticals (NASDAQ:TTPH), a biopharmaceutical company focused on developing and commercializing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today announced that the European Commission (EC) has adopted the Decision granting marketing authorisation for XERAVA (eravacycline) for injection for the treatment of complicated intra-abdominal infectio...

STAT Plus: Generic drug makers face ‘a silent crisis,’ FDA official says, and raising prices could help

A drug company raising its prices might actually encourage other generic companies to jump into the market, Janet Woodcock said.

Baird $SRPT No change to outlook after negative CHMP opinion. announced that the CHMP will maintain its negative opinion with respect to the outstanding application for approval of eteplirsen to treat DMD patients with an exon 51 skipping mutation. announ

Baird $SRPT No change to outlook after negative CHMP opinion. announced that the CHMP will maintain its negative opinion with respect to the outstanding application for approval of eteplirsen to treat DMD patients with an exon 51 skipping mutation. announcement comes as expected

Eli Lilly's Emgality backed for approval in Europe for prevention of #migraine https://www.firstwordpharma.com/node/1592554  $LLY

Eli Lilly's Emgality backed for approval in Europe for prevention of #migraine https://www.firstwordpharma.com/node/1592554  $LLY

New #medicine for the prevention of #migraine recommended for approval: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/09/news_detail_003024.jsp&mid=WC0b01ac058004d5c1 … #CHMP

New #medicine for the prevention of #migraine recommended for approval: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/09/news_detail_003024.jsp&mid=WC0b01ac058004d5c1 … #CHMP

Sun Pharma Receives Australian Agency Approval of Ilumya

NewsIlumya is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.Contributed Autho

Vabomere, a combination of an #antibiotic and new beta-lactamase inhibitor was recommended for approval: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/09/news_detail_003026.jsp&mid=WC0b01ac058004d5c1 … #antimicrobialresis

Vabomere, a combination of an #antibiotic and new beta-lactamase inhibitor was recommended for approval: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/09/news_detail_003026.jsp&mid=WC0b01ac058004d5c1 … #antimicrobialresistance

Bayer Receives FDA Approval for Jivi

NewsJivi works by replacing the reduced or missing factor VIII (FVIII) in adults and adolescents 12 years of age or older with hemophilia A. Contributed Author: 

Novartis ‘disappointed’ and ‘surprised’ by NICE CAR-T call

NICE has deemed Novartisâ CAR T-cell therapy Kymriah too expensive for the UK market.

News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 September 2018

CHMP elects new chair and recommends thirteen medicines for approval

News and press releases: New gene therapy for rare inherited disorder causing vision loss recommended for approval

Luxturna is the first treatment option for hereditary retinal dystrophy with mutations of the RPE65 gene

Adalimumab and trastuzumab biosimilars gain EC approval

A trastuzumab biosimilar from Pfizer and three adalimumab biosimilars from Sandoz have been approved by the European Commission (EC).

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