Cyclopropanes

Vanda Pharmaceuticals FDA Update for HETLIOZ® in the Treatment of Jet Lag Disorder

Retrieved on: 
Monday, August 19, 2019
Melatonin receptor agonists, Benzofurans, Cyclopropanes, Sedatives, Tasimelteon, Vanda, Food and Drug Administration, Health, Chemistry, Government agencies

In the CRL, the FDA asserted that these measures demonstrating improved sleep are of unclear clinical significance.

Key Points: 
  • In the CRL, the FDA asserted that these measures demonstrating improved sleep are of unclear clinical significance.
  • Vanda intends to consider each observation as it plans for continued engagement with the FDA on this matter.
  • "Vanda remains committed to obtaining FDA marketing approval for tasimelteon in Jet Lag Disorder in order to address this significant unmet medical need."
  • Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf.

NIH to Evaluate Iclaprim Activity against Listeria

Retrieved on: 
Monday, August 19, 2019
Chemical compounds, Pyrimidines, Cyclopropanes, Aromatic amines, Iclaprim, Antibiotics, Skin and skin structure infection, Food and Drug Administration, Fast track, Indication, Lipoglycopeptide, Brilacidin

Motif Bio is seeking approval of iclaprim from the U.S. Food & Drug Administration (FDA) for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

Key Points: 
  • Motif Bio is seeking approval of iclaprim from the U.S. Food & Drug Administration (FDA) for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
  • In February 2019, the Company received a Complete Response Letter (CRL) related to the New Drug Application (NDA) for iclaprim for the treatment of ABSSSI.
  • Iclaprim received Qualified Infectious Disease Product (QIDP) designation from the FDA together with Fast Track status for the ABSSSI indication.
  • Additionally, there can be no assurance that Motif Bio will regain compliance with Nasdaq rules or maintain its ADS listing on Nasdaq.

Motif Bio and Hercules Capital Amend Loan and Security Agreement

Retrieved on: 
Thursday, August 1, 2019
Chemical compounds, Pyrimidines, Cyclopropanes, Iclaprim, Skin and skin structure infection, Food and Drug Administration, Antibiotics

Motif Bio is seeking approval of iclaprim from the U.S. Food & Drug Administration (FDA) for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

Key Points: 
  • Motif Bio is seeking approval of iclaprim from the U.S. Food & Drug Administration (FDA) for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
  • Motif Bio has been granted a meeting, scheduled for September 19, 2019, with the Agency to discuss the proposed patient population and study design.
  • Additionally, there can be no assurance that Motif Bio will regain compliance with Nasdaq rules or maintain its ADS listing on Nasdaq.
  • Motif Bio undertakes no obligation to update or revise any forward-looking statements.

Enanta’s HCV Collaboration Partner AbbVie receives Approval by the European Commission for MAVIRET™ (glecaprevir/pibrentasvir) to Shorten Treatment Duration to Eight Weeks for Treatment-Naïve HCV Patients with Compensated Cirrhosis

Retrieved on: 
Friday, August 2, 2019
Biotechnology, Pharmaceutical, Health, Chemistry, Chemical compounds, Organic compounds, RTT, Cyclopropanes, Sulfonamides, Combination drugs, Organofluorides, Glecaprevir/pibrentasvir, Glecaprevir, Cirrhosis, Hepatitis C

An analysis from the same clinical trial evaluating MAVIRET as an 8-week, once-daily treatment option for treatment-nave, compensated cirrhotic, GT3 HCV patients is ongoing.

Key Points: 
  • An analysis from the same clinical trial evaluating MAVIRET as an 8-week, once-daily treatment option for treatment-nave, compensated cirrhotic, GT3 HCV patients is ongoing.
  • MAVIRET is already approved as an 8-week, pan-genotypic (GT1-6) treatment for treatment-nave patients without cirrhosis.
  • The recommended duration of therapy for treatment nave GT3 HCV patients with compensated cirrhosis is 12 weeks.
  • Preliminary Efficacy and Safety of 8-Week Glecaprevir/Pibrentasvir in Patients with HCV Genotype 16 Infection and Compensated Cirrhosis: The EXPEDITION-8 Study.

Exelixis Announces Second Quarter 2019 Financial Results and Provides Corporate Update

Retrieved on: 
Wednesday, July 31, 2019
Oncology, Health, Genetics, Pharmaceutical, Biotechnology, Exelixis, Cyclopropanes, Quinolines, Tyrosine kinase inhibitors, Cabozantinib, NASDAQ, Economy of the United States, Chemical substances, Companies

Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the second quarter of 2019 and provided an update on progress toward fulfilling its key corporate objectives, as well as discovery, development and commercial milestones.

Key Points: 
  • Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the second quarter of 2019 and provided an update on progress toward fulfilling its key corporate objectives, as well as discovery, development and commercial milestones.
  • The second quarter of 2019 was highlighted by the strong and sustained momentum of our business, said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis.
  • Based upon Exelixis partner Ipsens cabozantinib-related revenues in the second quarter of 2019 of approximately $67 million, Exelixis earned $14.9 million in royalty revenues at the 22% royalty rate.
  • Exelixis management will discuss the companys financial results for the second quarter of 2019 and provide a general business update during a conference call beginning at 5:00 p.m. EDT / 2:00 p.m. PDT today, Wednesday, July 31, 2019.

‘CURE Expert Connections®’ Presents ‘Overcoming the Odds,’ a Video Series Outlining the Journey of a Stage 4 Renal Cell Cancer Survivor

Retrieved on: 
Tuesday, July 30, 2019
Other Health, Oncology, Women, Hospitals, MEN, Family, Science, Consumer, Other Science, Research, Health, Cancer, Medicine, Clinical medicine, Cabozantinib, Cyclopropanes, Quinolines, Metástasis

We are excited to launch this video series, said Michael J. Hennessy Jr., president of MJH Associates, Inc., parent company of CURE Media Group.

Key Points: 
  • We are excited to launch this video series, said Michael J. Hennessy Jr., president of MJH Associates, Inc., parent company of CURE Media Group.
  • It is revitalizing to experience Gallants triumph over RCC as his story is shared with both DSilva and the audience.
  • Throughout the series, Gallant and DSilva discuss Gallants journey to overcome this aggressive and metastatic disease, specifically with cabozantinib treatment.
  • CURE Expert Connections is a video platform designed specifically for patients with cancer featuring information, stories and advice about the cancer journey.

Alkermes Announces Settlement With Amneal Over VIVITROL® Patent Dispute

Retrieved on: 
Monday, July 29, 2019
Chemical compounds, Organic compounds, Articles, Alkermes, Opioid antagonists, Morphinans, Amneal Pharmaceuticals, Cyclopropanes, Ketones, Naltrexone, Inter partes review, Generic drug

DUBLIN, July 29, 2019 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) announced today that it has entered into a settlement and license agreement (the agreement) with Amneal Pharmaceuticals LLC (Amneal) to resolve Amneal's inter partes review (IPR) petition challenging U.S. Patent Number 7,919,499 ('499 Patent), an Orange Book-listed patent for VIVITROL (naltrexone for extended-release injectable suspension) that expires in 2029.

Key Points: 
  • DUBLIN, July 29, 2019 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) announced today that it has entered into a settlement and license agreement (the agreement) with Amneal Pharmaceuticals LLC (Amneal) to resolve Amneal's inter partes review (IPR) petition challenging U.S. Patent Number 7,919,499 ('499 Patent), an Orange Book-listed patent for VIVITROL (naltrexone for extended-release injectable suspension) that expires in 2029.
  • Under the agreement, the parties agreed to request termination of the IPR and Alkermes granted Amneal the non-exclusive right to market a generic formulation of VIVITROL in the U.S. beginning sometime in 2028 or earlier under certain circumstances.
  • "We believe this settlement recognizesthe strength of the VIVITROL intellectual property.
  • We are pleased to come to this resolution which provides more clarity regarding the outlook for VIVITROL," said Richard Pops, Chief Executive Officer of Alkermes.

Alkermes Announces Settlement With Amneal Over VIVITROL® Patent Dispute

Retrieved on: 
Monday, July 29, 2019
Chemical compounds, Organic compounds, Articles, Alkermes, Opioid antagonists, Morphinans, Amneal Pharmaceuticals, Cyclopropanes, Ketones, Naltrexone, Inter partes review, Generic drug

DUBLIN, July 29, 2019 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) announced today that it has entered into a settlement and license agreement (the agreement) with Amneal Pharmaceuticals LLC (Amneal) to resolve Amneal's inter partes review (IPR) petition challenging U.S. Patent Number 7,919,499 ('499 Patent), an Orange Book-listed patent for VIVITROL (naltrexone for extended-release injectable suspension) that expires in 2029.

Key Points: 
  • DUBLIN, July 29, 2019 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) announced today that it has entered into a settlement and license agreement (the agreement) with Amneal Pharmaceuticals LLC (Amneal) to resolve Amneal's inter partes review (IPR) petition challenging U.S. Patent Number 7,919,499 ('499 Patent), an Orange Book-listed patent for VIVITROL (naltrexone for extended-release injectable suspension) that expires in 2029.
  • Under the agreement, the parties agreed to request termination of the IPR and Alkermes granted Amneal the non-exclusive right to market a generic formulation of VIVITROL in the U.S. beginning sometime in 2028 or earlier under certain circumstances.
  • "We believe this settlement recognizesthe strength of the VIVITROL intellectual property.
  • We are pleased to come to this resolution which provides more clarity regarding the outlook for VIVITROL," said Richard Pops, Chief Executive Officer of Alkermes.

Court Upholds The Validity And Determined Actavis' Infringement Of Patent Protecting RELISTOR® Tablets

Retrieved on: 
Thursday, July 18, 2019
Chemical compounds, Life sciences, Pharmaceutical companies, Alcohols, Cyclopropanes, Ketones, Methylnaltrexone, Morphinans, Phenols, Actavis, Bausch Health, Teva Pharmaceutical Industries

BRIDGEWATER, N.J. and NEW YORK, July 17, 2019 /PRNewswire/ --Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") and Progenics Pharmaceuticals (NASDAQ: PGNX), announced today that the U.S. District Court of New Jersey upheld the validity and determined Actavis' infringement of a patent protecting RELISTOR (methylnaltrexone bromide) tablets, expiring March 2031.

Key Points: 
  • BRIDGEWATER, N.J. and NEW YORK, July 17, 2019 /PRNewswire/ --Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") and Progenics Pharmaceuticals (NASDAQ: PGNX), announced today that the U.S. District Court of New Jersey upheld the validity and determined Actavis' infringement of a patent protecting RELISTOR (methylnaltrexone bromide) tablets, expiring March 2031.
  • Defendant, Actavis Laboratories FL, Inc., a subsidiary of Teva Pharmaceutical Industries Ltd, had challenged the validity of and had alleged non-infringement of Claims 2 and 5 of U.S. Patent No.
  • 8,524,276, which protects the formulation of RELISTOR tablets.
  • Bausch Health is not aware of any other ANDAs filed with the FDA seeking approval of a generic version of RELISTOR tablets, and will continue to vigorously defend its intellectual property in these and other claims.

Exelixis Updates Phase 1b COSMIC-021 Trial of Cabozantinib in Combination With Atezolizumab in Patients With Advanced Solid Tumors

Retrieved on: 
Monday, July 15, 2019
Biotechnology, General Health, Health, Pharmaceutical, Oncology, Research, Science, Clinical trials, Tyrosine kinase inhibitors, Antineoplastic drugs, Cabozantinib, Cyclopropanes, Quinolines, Chemical substances, the COSMIC-021 Study, CABOMETYX® (cabozantinib)

The single-agent cabozantinib cohort will initially enroll up to 30 patients, and the single agent atezolizumab cohort will initially enroll up to 10 patients.

Key Points: 
  • The single-agent cabozantinib cohort will initially enroll up to 30 patients, and the single agent atezolizumab cohort will initially enroll up to 10 patients.
  • COSMIC-021 is a multicenter, phase 1b, open-label study that is divided into two parts: a dose-escalation phase and an expansion cohort phase.
  • In a fourth exploratory cohort, approximately 10 patients with advanced CRPC will be treated in a single-agent atezolizumab cohort.
  • Exploratory cohorts have the option to be expanded up to 80 patients (cabozantinib) and 30 patients (atezolizumab) total.