Merck & Co.

Shorla Oncology Welcomes Rayna Sethi Herman as Chief Commercial Officer

Retrieved on: 
Thursday, December 7, 2023

Shorla Oncology (‘Shorla’), a US-Ireland specialty pharmaceutical company, has announced the appointment of Rayna Sethi Herman as Chief Commercial Officer (CCO).

Key Points: 
  • Shorla Oncology (‘Shorla’), a US-Ireland specialty pharmaceutical company, has announced the appointment of Rayna Sethi Herman as Chief Commercial Officer (CCO).
  • Most recently, she served as CCO at EVERSANA, the leading provider of commercial services to the life sciences industry.
  • “We are delighted to have Rayna join our team,” said Sharon Cunningham, Chief Executive Officer at Shorla Oncology.
  • “I am thrilled to be joining Shorla Oncology as Chief Commercial Officer," said Rayna Sethi Herman.

Merck Animal Health Receives Positive CVMP Opinion for an Injectable Formulation of BRAVECTO® (Fluralaner) for Use in Dogs

Retrieved on: 
Monday, December 11, 2023

Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE:MRK), today announced that the European Medicines Agency’s Committee for Veterinary Medicinal Products (CVMP) issued a positive opinion for BRAVECTO® (fluralaner) 150 mg/ml powder and solvent for suspension for injection for dogs.

Key Points: 
  • Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE:MRK), today announced that the European Medicines Agency’s Committee for Veterinary Medicinal Products (CVMP) issued a positive opinion for BRAVECTO® (fluralaner) 150 mg/ml powder and solvent for suspension for injection for dogs.
  • If the European Commission (EC) adopts the recommendation, this injectable formulation of BRAVECTO can be used by or under the supervision of a veterinarian and for administration to dogs and puppies six months of age and older.
  • “Since our initial launch of BRAVECTO nearly a decade ago, Merck Animal Health has been committed to bringing innovations to our customers that protect pets longer from flea and tick infestations and the associated health risks,” said Rick DeLuca, executive vice president and president, Merck Animal Health.
  • “If approved, a once-yearly dosing of BRAVECTO injectable can provide a long duration of protection, simplifying care for both pet owners and veterinarians.

Merck Announces KEYLYNK-008 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus LYNPARZA® (olaparib) for Patients With Metastatic Squamous Non-Small Cell Lung Cancer to Stop for Futility

Retrieved on: 
Thursday, December 7, 2023

Merck is discontinuing the study based on the recommendation of an independent Data Monitoring Committee (DMC), which reviewed data from a planned interim analysis (IA3).

Key Points: 
  • Merck is discontinuing the study based on the recommendation of an independent Data Monitoring Committee (DMC), which reviewed data from a planned interim analysis (IA3).
  • The safety profile in this trial was consistent with that observed in previously reported studies for the individual therapies and no new safety signals were identified.
  • Merck will inform study investigators of the recommendation from the DMC and advise patients in the study to speak to their physician regarding treatment.
  • “While there have been significant scientific advancements in lung cancer research in recent years, unmet needs remain for patients with advanced non-small cell lung cancer,” said Dr. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, Merck Research Laboratories.

Merck Announces Findings from Phase 2 KeyVibe-002 Trial Evaluating an Investigational Coformulation of Vibostolimab and Pembrolizumab in Previously Treated Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC)

Retrieved on: 
Thursday, December 7, 2023

Vibostolimab/pembrolizumab alone did not show an improvement in median PFS compared to docetaxel alone (2.7 months vs. 3.2 months; HR=1.40 [95% CI, 0.96-2.02]; p=0.9622).

Key Points: 
  • Vibostolimab/pembrolizumab alone did not show an improvement in median PFS compared to docetaxel alone (2.7 months vs. 3.2 months; HR=1.40 [95% CI, 0.96-2.02]; p=0.9622).
  • Vibostolimab/pembrolizumab plus docetaxel improved OS compared with docetaxel alone, though these results did not reach statistical significance (HR=0.76 [95% CI, 0.50-1.15]).
  • The safety profile of vibostolimab/pembrolizumab was consistent with that observed for vibostolimab and pembrolizumab in previously reported studies, with no new safety signals observed.
  • Ongoing Phase 3 studies in lung cancer include KeyVibe-003 , KeyVibe-006 , KeyVibe-007 and KeyVibe-008 , as well as KeyVibe-010 in melanoma.

Vertex Appoints Nancy Thornberry to its Board of Directors

Retrieved on: 
Tuesday, December 5, 2023

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Nancy Thornberry has been appointed to its Board of Directors as an independent director.

Key Points: 
  • Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Nancy Thornberry has been appointed to its Board of Directors as an independent director.
  • She founded and served as Chief Executive Officer of Kallyope until 2021 and remains on its Board of Directors and is Chair of Research & Development.
  • “Scientific innovation is a core Vertex value and Nancy brings to our Board deep scientific expertise and a remarkable track record of discovering and developing groundbreaking medicines.
  • And today, they are on the cusp of transforming the treatment of multiple additional serious diseases,” said Nancy Thornberry.

Gossamer Bio Announces Appointment of John Quisel, J.D., Ph.D., to its Board of Directors

Retrieved on: 
Wednesday, November 29, 2023

Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH), today announced the appointment of John Quisel, J.D., Ph.D., President and CEO of Disc Medicine, to its Board of Directors.

Key Points: 
  • Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH), today announced the appointment of John Quisel, J.D., Ph.D., President and CEO of Disc Medicine, to its Board of Directors.
  • “Today, we are thrilled to announce that Dr. John Quisel has joined the Gossamer team," said Faheem Hasnain, Chairman, Co-Founder and CEO of Gossamer Bio.
  • We are confident that Dr. Quisel’s appointment enhances our ability to get seralutinib to patients.”
    “I am honored to join Gossamer’s Board at this pivotal moment for the Company,” said Dr. Quisel.
  • During his tenure, Dr. Quisel also served in various roles, including Senior Vice President of Corporate Development and General Counsel.

Merck’s V116, an Investigational, 21-valent Pneumococcal Conjugate Vaccine Specifically Designed to Protect Adults, Demonstrated Superior Immunogenicity for 10 of 11 Unique Serotypes Compared to PCV20 in Adults 50 Years of Age and Older

Retrieved on: 
Tuesday, November 28, 2023

The trial evaluated the immunogenicity, tolerability and safety of V116 compared to PCV20 (pneumococcal 20-valent conjugate vaccine) in adults who had not previously received a pneumococcal vaccine.

Key Points: 
  • The trial evaluated the immunogenicity, tolerability and safety of V116 compared to PCV20 (pneumococcal 20-valent conjugate vaccine) in adults who had not previously received a pneumococcal vaccine.
  • In adults 18 to 49 years of age (Cohort 2), V116 elicited non-inferior immune responses (immunobridged) compared to adults 50 to 64 years of age, as assessed by serotype-specific OPA GMTs 30 days post-vaccination.
  • If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed for adults.
  • Participants administered V116 and PCV20 who reported at least 1 adverse event (AE) were 61.7% and 67.2%, respectively.

Merck to Acquire Caraway Therapeutics, Inc.

Retrieved on: 
Tuesday, November 21, 2023

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Caraway Therapeutics, Inc. announced today that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire Caraway Therapeutics for a total potential consideration of up to $610 million, including an undisclosed upfront payment as well as contingent milestone payments.

Key Points: 
  • Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Caraway Therapeutics, Inc. announced today that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire Caraway Therapeutics for a total potential consideration of up to $610 million, including an undisclosed upfront payment as well as contingent milestone payments.
  • The upfront payment will be expensed by Merck in the fourth quarter of 2023 and included in non-GAAP results.
  • The Board of Directors of Caraway Therapeutics has approved the transaction.
  • Merck, through its MRL Ventures Fund, has been a shareholder of Caraway Therapeutics since 2018.

Merck to Participate in the 6th Annual Evercore ISI HealthCONx Conference

Retrieved on: 
Monday, November 20, 2023

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, is scheduled to participate in a fireside chat at the 6th Annual Evercore ISI HealthCONx Conference on Thursday, Nov. 30, 2023, at 1:20 p.m.

Key Points: 
  • Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, is scheduled to participate in a fireside chat at the 6th Annual Evercore ISI HealthCONx Conference on Thursday, Nov. 30, 2023, at 1:20 p.m.
  • ET.

Xtrackers by DWS Launches US National Critical Technologies ETF

Retrieved on: 
Thursday, November 16, 2023

DWS, one of the world’s leading asset managers announced today the listing of a new exchange-traded fund (ETF), the Xtrackers US National Critical Technologies ETF (NYSE: CRTC) (the “Fund”), which is designed to provide investors with equity exposure to large and mid-cap companies from developed market countries that satisfy key criteria related to critical technology sectors and geopolitical risk ratings.

Key Points: 
  • DWS, one of the world’s leading asset managers announced today the listing of a new exchange-traded fund (ETF), the Xtrackers US National Critical Technologies ETF (NYSE: CRTC) (the “Fund”), which is designed to provide investors with equity exposure to large and mid-cap companies from developed market countries that satisfy key criteria related to critical technology sectors and geopolitical risk ratings.
  • These critical technologies range from emerging opportunity fields such as biotechnology and quantum science to wider areas such as microelectronics and renewable energy.
  • “In our ongoing build-out of the Xtrackers ETF offering in the US market, we continue to focus on key strategic themes in the current economic environment as well as the foreseeable future.
  • “Our new Xtrackers US National Critical Technologies ETF leverages a geostrategic risk rating that evaluates risks on different levels.