Pamlab

Intercept Announces FDA Acceptance of Supplemental New Drug Application for Ocaliva® (obeticholic acid) for the Treatment of PBC

Retrieved on: 
Thursday, February 29, 2024
Therapy, Senior, Ursodeoxycholic acid, Pamlab, New Drug Application, FDA, Food, Shanda, PDUFA, Regulatory affairs, Database, PBC, Communication, Hepatology, Cirrhosis, Intercept, Primary biliary cholangitis, Patient, UDCA, Obeticholic acid, Intercept Pharmaceuticals, Advisory Committee, Pharmaceutical industry

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 15, 2024.

Key Points: 
  • The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 15, 2024.
  • In this communication, the agency informed Intercept that they are planning to hold an Advisory Committee meeting to discuss the application.
  • The precedent-setting sNDA for Ocaliva is intended to satisfy the post-marketing requirements to confirm a clinical benefit in patients with PBC.
  • Intercept and Alfasigma remain committed to supporting people living with PBC and look forward to advancing discussions with the agency.

Industry Veteran Abbas Hussain Appointed as Chair of Asceneuron

Retrieved on: 
Monday, December 18, 2023
SAN, Chair, Teva Pharmaceuticals, Abingworth (company), Patient, Adviser, Sofinnova, Spondyloarthropathy, Medicinal chemistry, Capital, CSL Limited, Stanford University, Eli Lilly, Pamlab, Conference, CSL Vifor, Non-executive director, Growth, GSK plc, OGA, Cochlear Limited, Pharmaceutical industry, Science, Immunocore

Abbas Hussain has over 35 years of experience in the healthcare industry, building and growing businesses across the globe.

Key Points: 
  • Abbas Hussain has over 35 years of experience in the healthcare industry, building and growing businesses across the globe.
  • Abbas Hussain, Chair of the Board of Directors of Asceneuron, remarked: "There have been tremendous advances in the treatment of neurodegenerative disorders which impact millions of people globally every year.
  • Abbas currently holds various Non-Executive Director and Advisor roles at Alfasigma SpA, 4Bio Capital, C-Bridge Capital and GLG Institute.
  • In addition, Abbas also provides expert advisory services to private equity and venture capital firms focused on the healthcare sector.

Industry Veteran Abbas Hussain Appointed as Chair of Asceneuron

Retrieved on: 
Monday, December 18, 2023
SAN, Chair, Teva Pharmaceuticals, Abingworth (company), Patient, Adviser, Sofinnova, Spondyloarthropathy, Medicinal chemistry, Capital, CSL Limited, Stanford University, Eli Lilly, Pamlab, Conference, CSL Vifor, Non-executive director, Growth, GSK plc, OGA, Cochlear Limited, Pharmaceutical industry, Science, Immunocore

Abbas Hussain has over 35 years of experience in the healthcare industry, building and growing businesses across the globe.

Key Points: 
  • Abbas Hussain has over 35 years of experience in the healthcare industry, building and growing businesses across the globe.
  • Abbas Hussain, Chair of the Board of Directors of Asceneuron, remarked: "There have been tremendous advances in the treatment of neurodegenerative disorders which impact millions of people globally every year.
  • Abbas currently holds various Non-Executive Director and Advisor roles at Alfasigma SpA, 4Bio Capital, C-Bridge Capital and GLG Institute.
  • In addition, Abbas also provides expert advisory services to private equity and venture capital firms focused on the healthcare sector.

Alfasigma completes acquisition of Intercept Pharmaceuticals, Inc.

Retrieved on: 
Wednesday, November 8, 2023
Bezafibrate, Gastroenterology, Obeticholic acid, FDA, Delaware General Corporation Law, Food, Tax, Medication, Intercept Pharmaceuticals, Intercept, Liver, Acquisition, PBC, Primary biliary cholangitis, Autoimmune disease, USD, Hepatology, Patient, DNA, Food and Drug Administration, Holding company, Pharmaceutical industry, Pamlab

BOLOGNA, Italy and MORRISTOWN, N.J., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Alfasigma S.p.A. (“Alfasigma”) and Intercept Pharmaceuticals, Inc. (“Intercept”) announced today the completion of the acquisition of Intercept by Alfasigma through its wholly owned subsidiary Interstellar Acquisition Inc.

Key Points: 
  • BOLOGNA, Italy and MORRISTOWN, N.J., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Alfasigma S.p.A. (“Alfasigma”) and Intercept Pharmaceuticals, Inc. (“Intercept”) announced today the completion of the acquisition of Intercept by Alfasigma through its wholly owned subsidiary Interstellar Acquisition Inc.
  • As a result of the transaction, Intercept has become a wholly owned subsidiary of Alfasigma, and the common stock of Intercept has ceased to be traded on the NASDAQ Stock Market.
  • Stefano Golinelli, Chairman of Alfasigma, commented: “At Alfasigma, the passion we have for Pharmaceuticals is in our DNA - and a driver for our ambitious international growth plans.
  • Francesco Balestrieri, CEO of Alfasigma, added: “Today, we complete a transformational acquisition which strongly aligns with our strategy of building a solid presence in gastroenterology and hepatology, Alfasigma’s core business areas.

Alfasigma completes acquisition of Intercept Pharmaceuticals, Inc.

Retrieved on: 
Wednesday, November 8, 2023
Health, Other Health, Research, Pharmaceutical, Science, Biotechnology, Bezafibrate, Gastroenterology, Obeticholic acid, FDA, Delaware General Corporation Law, Food, Tax, Medication, Intercept Pharmaceuticals, Intercept, Liver, Acquisition, United, PBC, Primary biliary cholangitis, Autoimmune disease, USD, Hepatology, Patient, DNA, Food and Drug Administration, Holding company, Pharmaceutical industry, Pamlab

Alfasigma S.p.A. (“Alfasigma”) and Intercept Pharmaceuticals, Inc. ( “Intercept”) announced today the completion of the acquisition of Intercept by Alfasigma through its wholly owned subsidiary Interstellar Acquisition Inc.

Key Points: 
  • Alfasigma S.p.A. (“Alfasigma”) and Intercept Pharmaceuticals, Inc. ( “Intercept”) announced today the completion of the acquisition of Intercept by Alfasigma through its wholly owned subsidiary Interstellar Acquisition Inc.
  • As a result of the transaction, Intercept has become a wholly owned subsidiary of Alfasigma, and the common stock of Intercept has ceased to be traded on the NASDAQ Stock Market.
  • Stefano Golinelli, Chairman of Alfasigma, commented: “At Alfasigma, the passion we have for Pharmaceuticals is in our DNA - and a driver for our ambitious international growth plans.
  • Thus, we are delighted to announce the successful outcome of our tender offer for Intercept Pharmaceuticals, Inc.

Alfasigma S.p.A. successfully completes tender offer for all outstanding shares of common stock of Intercept Pharmaceuticals, Inc.

Retrieved on: 
Wednesday, November 8, 2023
Health, Pharmaceutical, Computershare, Delaware General Corporation Law, Eastern Time Zone, Tax, Intercept Pharmaceuticals, Intercept, Acquisition, Judgement, Risk, USD, Security (finance), Cryptocurrency, Pamlab

The tender offer expired as scheduled at one minute after 11:59 p.m., Eastern Time on November 7, 2023 (12:00 midnight, Eastern Time, on November 8, 2023).

Key Points: 
  • The tender offer expired as scheduled at one minute after 11:59 p.m., Eastern Time on November 7, 2023 (12:00 midnight, Eastern Time, on November 8, 2023).
  • As of the expiration, 31,158,412 shares of common stock of Intercept had been validly tendered and not validly withdrawn, representing approximately 74.5 percent of Intercept’s outstanding shares of common stock, according to the depositary for the tender offer.
  • The conditions to the tender offer were satisfied, and Alfasigma and Interstellar have accepted for payment and will promptly pay the depositary for all validly tendered shares.
  • Upon completion of the merger, Intercept will become a wholly owned subsidiary of Alfasigma, and the common stock of Intercept will cease to be traded on the NASDAQ Stock Market.

Galapagos reports third quarter 2023 results and releases new encouraging data from CAR-T studies for presentation at ASH 2023

Retrieved on: 
Thursday, November 2, 2023
B-cell lymphoma, Rheumatoid arthritis, Mantle cell lymphoma, Symantec Endpoint Protection, Ulcerative colitis, Pulmonary embolism, Lupus, CET, Infection, SLE, RT, Bleeding, ORR, Safety, Patient, TYK2, Baltic, DLBCL, CR, Euronext, Galapagos NV, Failure mode and effects analysis, ASH, UK, Follicular lymphoma, Letter, CRS, Non-Hodgkin lymphoma, Survival, ET, Technology transfer, CRR, UC, CD19, Indolent lymphoma, CFO, Burn, Lymphoid leukemia, Pharmaceutical industry, Cryptocurrency, Vaccine, Uranium mining, Pamlab, Galápagos Islands, Dermatomyositis, Central Europe

Overall, 11 of 12 patients responded to treatment (ORR of 92%) and 9 of 12 patients achieved a CRR (75%).

Key Points: 
  • Overall, 11 of 12 patients responded to treatment (ORR of 92%) and 9 of 12 patients achieved a CRR (75%).
  • Overall, 11 of 13 patients responded to treatment (ORR of 85%) and 9 of 13 patients achieved a CRR (69%).
  • New preliminary data (data cut-off: 26 April 2023), for 12 patients enrolled in EUPLAGIA-1, will be presented at ASH (see ASH abstract and poster presentation details below).
  • New preliminary data (data cut-off: 2 May 2023) for 14 patients enrolled in ATALANTA-1 will be presented at ASH (see ASH abstract and poster presentation details below).

Galapagos concludes strategic evaluation and signs letter of intent to transfer Jyseleca® business to Alfasigma

Retrieved on: 
Monday, October 30, 2023
Linda, Euronext, International Financial Reporting Standards, Galapagos NV, International Air Transport Association code, Thirty-second Amendment of the Constitution Bill 2013, International, Committee, Filgotinib, Workforce, News, Acquisition, Related party transaction, UK, Statutory auditor, CET, Collaboration, CFO, European, Patient, Letter, Cryptocurrency, Pharmaceutical industry, Management, Commercial property, Audit, Pamlab, Galápagos Islands

Galapagos will pay up to €40 million by June 2025 to Alfasigma for Jyseleca® related development activities.

Key Points: 
  • Galapagos will pay up to €40 million by June 2025 to Alfasigma for Jyseleca® related development activities.
  • “Today’s news is the result of a thoughtful, in-depth analysis, and represents the successful conclusion of the strategic evaluation process for Jyseleca®.
  • The acquisition of Galapagos' Jyseleca® business represents another important milestone in Alfasigma's international transformation and growth path and fits perfectly with our Company's core business areas.
  • It is the intention in the contemplated transaction between Galapagos and Alfasigma that the amended Filgotinib Agreement will be assigned by Galapagos to Alfasigma.

Alfasigma S.p.A. Announces Expiration of Hart-Scott-Rodino Waiting Period in Connection with Pending Acquisition of Intercept Pharmaceuticals, Inc.

Retrieved on: 
Thursday, October 26, 2023
Pharmaceutical, Finance, General Health, Health, Banking, Professional Services, Vitamins, Supplements, Business, HSR, 600 (number), Eastern Time Zone, Intercept Pharmaceuticals, Intercept, Money transmitter, Acquisition, Ix, Nature, Risk, Letter of transmittal, Letter, Annual report, Schedule, Failure, Hart–Scott–Rodino Antitrust Improvements Act, Uncertainty, Transaction, Cryptocurrency, Pamlab

The expiration of the HSR Act waiting period satisfies one of the conditions to consummate the tender offer.

Key Points: 
  • The expiration of the HSR Act waiting period satisfies one of the conditions to consummate the tender offer.
  • Other customary offer conditions remain to be satisfied, including, among others, a minimum tender of at least a majority of outstanding Intercept common stock.
  • Any forward-looking statements in this release are based upon information known to Alfasigma on the date of this announcement.
  • Neither Alfasigma nor Intercept undertakes any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Alfasigma S.p.A. Tender Offer for Intercept Pharmaceuticals, Inc. Commences

Retrieved on: 
Wednesday, October 11, 2023
Health, Pharmaceutical, Intercept Pharmaceuticals, Schedule, Eastern Time Zone, 600 (number), Risk, USD, Agreement, Transaction, Intercept, Failure, Expiration, Tax, Computershare, Money transmitter, Plan, Hart–Scott–Rodino Antitrust Improvements Act, Annual report, Letter, Uncertainty, Ix, Nature, Security (finance), Cryptocurrency, Pamlab

Alfasigma will file today a Tender Offer Statement on Schedule TO with the United States Securities and Exchange Commission (the “SEC”).

Key Points: 
  • Alfasigma will file today a Tender Offer Statement on Schedule TO with the United States Securities and Exchange Commission (the “SEC”).
  • The Offer to Purchase contained within the Schedule TO sets out the full terms and conditions of the Offer.
  • This press release is neither an offer to purchase nor a solicitation of an offer to sell securities, nor is it a substitute for any tender offer materials that Intercept or Alfasigma will file with the SEC.
  • On October 11, 2023, Purchaser and Alfasigma will file a Tender Offer Statement on Schedule TO with the SEC and Intercept will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC, in each case with respect to the Offer.