Medicines and Healthcare products Regulatory Agency

HUTCHMED Announces that Takeda Receives U.S. FDA Approval of FRUZAQLA™ (fruquintinib) for Previously Treated Metastatic Colorectal Cancer

Retrieved on: 
Thursday, November 9, 2023

HONG KONG, SHANGHAI, China and FLORHAM PARK, N.J., Nov. 09, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (Nasdaq/AIM:​HCM, HKEX:​13) (“HUTCHMED”) today announced that its partner Takeda received approval from the U.S. Food and Drug Administration (“FDA”) for FRUZAQLA™ (fruquintinib), an oral targeted therapy for adults with metastatic colorectal cancer (“CRC”) who have been previously treated with fluoropyrimidine-, oxaliplatin‑, and irinotecan‑based chemotherapy, an anti‑vascular endothelial growth factor (“VEGF”) therapy, and, if RAS wild‑type and medically appropriate, an anti-epidermal growth factor receptor (EGFR) therapy. FRUZAQLA is the first and only selective inhibitor of all three VEGF receptor kinases approved in the U.S. for previously treated metastatic CRC regardless of biomarker status.1,2 This approval was received under Priority Review more than 20 days ahead of the scheduled Prescription Drug Users Fee Act (PDUFA) date of November 30, 2023.

Key Points: 
  • The FDA approval of FRUZAQLA triggers a US$35 million milestone payment from Takeda.
  • Fruquintinib is developed and marketed in China by HUTCHMED following approval in September 2018, under the brand name ELUNATE™, in partnership with Eli Lilly and Company.
  • The trials investigated FRUZAQLA plus best supportive care versus placebo plus best supportive care in patients with previously treated mCRC.
  • A submission to the Japan Pharmaceuticals and Medical Devices Agency (“PMDA”) also took place in September 2023 .

Cocrystal Pharma to Discuss Progress with Novel Inhaled and Oral Influenza A Antiviral CC-42344 at the World Vaccine Congress West Coast

Retrieved on: 
Thursday, November 9, 2023

BOTHELL, Wash., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”), announces that President and co-CEO Sam Lee, PhD will discuss progress in developing the novel, broad-spectrum PB2 inhibitor CC-42344 in an oral presentation, “Taking a new route: Development of novel inhaled and oral influenza antiviral, CC-42344” at the World Vaccine Congress West Coast on Tuesday, November 28, 2023 at 3:20 p.m. Pacific Time.

Key Points: 
  • BOTHELL, Wash., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”), announces that President and co-CEO Sam Lee, PhD will discuss progress in developing the novel, broad-spectrum PB2 inhibitor CC-42344 in an oral presentation, “Taking a new route: Development of novel inhaled and oral influenza antiviral, CC-42344” at the World Vaccine Congress West Coast on Tuesday, November 28, 2023 at 3:20 p.m. Pacific Time.
  • The conference is being held November 27-30 at the Santa Clara Convention Center in Santa Clara, Calif.
    “It is highly gratifying to be selected for an oral presentation at this prestigious gathering to discuss the significant progress we’ve made in developing CC-42344 for the treatment of pandemic and seasonal influenza A,” said Dr. Lee.
  • “We recently announced authorization by the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) to initiate a Phase 2a human challenge trial with orally administered CC-42344 and we expect to begin treating influenza-infected patients later in this quarter.
  • Additionally, preparations are underway to begin a Phase 1 clinical trial in the first half of 2024 with an inhaled CC-42344 formulation as a potential treatment and prophylaxis for influenza A.”
    Following the presentation, Cocrystal will issue a press release with highlights from Dr. Lee’s discussion and the slide presentation will be available on the Company’s website .

Takeda Receives U.S. FDA Approval of FRUZAQLA™ (fruquintinib) for Previously Treated Metastatic Colorectal Cancer

Retrieved on: 
Wednesday, November 8, 2023

"There is a pressing need for new treatments for individuals with metastatic colorectal cancer, who have had limited options and continue to face poor outcomes.

Key Points: 
  • "There is a pressing need for new treatments for individuals with metastatic colorectal cancer, who have had limited options and continue to face poor outcomes.
  • “For far too long, healthcare providers and patients have had limited options when selecting a therapy for metastatic colorectal cancer.
  • The trials investigated FRUZAQLA plus best supportive care versus placebo plus best supportive care in patients with previously treated mCRC.
  • “Colorectal cancer is a highly heterogeneous disease, making it difficult to bring advancements to patients whose cancer has metastasized.

ADHD drug shortages are affecting patients in the UK – here's why they're happening

Retrieved on: 
Tuesday, November 7, 2023

Millions of people in the UK who take drugs for attention deficit hyperactivity disorder (ADHD) are facing difficulties getting their prescriptions filled due to shortages.

Key Points: 
  • Millions of people in the UK who take drugs for attention deficit hyperactivity disorder (ADHD) are facing difficulties getting their prescriptions filled due to shortages.
  • These shortages are currently affecting four of the five types of medicine licensed in the UK to treat ADHD.

What’s causing these shortages?

  • Not only that, but a growing number of adults are now being diagnosed with ADHD – meaning that even more people are seeking access to ADHD drugs.
  • For example, between April and June 2023 about 202,000 new people in England received a prescription for these drugs.
  • Multiple factors have been linked to this shortage – including a manufacturing delays, increased demand, restrictions on what drugs pharmacists can supply and quota issues.
  • In the US, the quotas may be too low, manufacturing may not be optimised, or the right people may not be receiving the products, causing shortages.
  • There are now reports that people are also having difficulty filling other ADHD medications, such as Concerta and Focalin.

Managing shortages

  • They can help them concentrate better, be less impulsive, feel calmer and learn and practise new skills.
  • Some patients report rationing their prescriptions to make them last longer or have taken to stockpiling them.
  • Patients who have been affected will have been notified by their normal pharmacy of any supply issues.
  • Changing medications or prescribed dosages can sometimes be a strategy to manage shortages so that patients can continue treatment.
  • It’s also unclear if the shortages will be resolved by the end of 2023 as predicted.


The authors do not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.

EQS-News: CHEPLAPHARM opens presence in Tokyo

Retrieved on: 
Tuesday, November 7, 2023

CHEPLAPHARM Arzneimittel GmbH, based in Greifswald/Germany, has opened a presence in the Japanese capital Tokyo and obtained the pharmaceutical licence for Japan.

Key Points: 
  • CHEPLAPHARM Arzneimittel GmbH, based in Greifswald/Germany, has opened a presence in the Japanese capital Tokyo and obtained the pharmaceutical licence for Japan.
  • The managing director of the founded CHEPLAPHARM KK is Kentaro Ichimori, who most recently held a leading position for Sandoz in Japan.
  • Establishing a presence in Japan and launching CHEPLAPHARM as a local brand is important to further build trust with local business partners, doctors and patients.
  • The opening of an office in Tokyo and the presence on the Japanese market serves to establish CHEPLAPHARM as a brand in Japan and make it better known, thus leveraging further growth potential.

Fennec Pharmaceuticals Announces Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, November 6, 2023

RESEARCH TRIANGLE PARK, N.C., Nov. 06, 2023 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a commercial stage specialty pharmaceutical company, today reported its financial results for the third quarter ended September 30, 2023 and provided a business update.

Key Points: 
  • ET ~
    RESEARCH TRIANGLE PARK, N.C., Nov. 06, 2023 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a commercial stage specialty pharmaceutical company, today reported its financial results for the third quarter ended September 30, 2023 and provided a business update.
  • “We continued to see strong commercial performance with PEDMARK® in the third quarter demonstrated by net product revenue of $6.5 million representing 96% quarter over quarter growth.
  • The Company had gross profit of $6.2 million for the third quarter of 2023.
  • ET, to discuss the Company’s financial results from the third quarter, ended September 30, 2023, and provide a business outlook for the remainder of 2023.

Krystal Biotech Announces Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, November 6, 2023

Financial results for the quarter ended September 30, 2023:

Key Points: 
  • Financial results for the quarter ended September 30, 2023:
    Cash, cash equivalents, and investments totaled $598.6 million on September 30, 2023.
  • For additional information on the Company’s financial results for the quarter ended September 30, 2023, please refer to the Form 10-Q filed with the SEC.
  • For additional information on the Company’s financial results for the nine months ended September 30, 2023, please refer to the Form 10-Q filed with the SEC.
  • Krystal Biotech will host a conference call to discuss its third quarter 2023 financial results and business highlights today, November 6, 2023, at 8:30 a.m.

Cocrystal Pharma Receives UK MHRA Authorization to Initiate Its Phase 2a Influenza Human Challenge Trial with Oral PB2 Inhibitor CC-42344

Retrieved on: 
Tuesday, October 31, 2023

In late 2022 Cocrystal reported highly favorable safety and tolerability results in the single-ascending and multiple-ascending dose portions of the healthy volunteer Phase 1 trial conducted in Australia.

Key Points: 
  • In late 2022 Cocrystal reported highly favorable safety and tolerability results in the single-ascending and multiple-ascending dose portions of the healthy volunteer Phase 1 trial conducted in Australia.
  • The Phase 2a single-site, double-blind, placebo-controlled human challenge trial will evaluate the safety, viral and clinical measurements of orally administered CC-42344 in subjects infected with influenza A.
  • “We are pleased to have met the regulatory requirements of the MHRA to begin this Phase 2a human challenge trial in the UK,” said Sam Lee, Ph.D., Cocrystal’s President and co-CEO.
  • “Influenza is a major global health threat that may become more challenging to treat due to emergence of highly pathogenic avian influenza viruses and resistance to approved influenza antivirals.

Sosei Heptares Announces Submission of New Drug Application in Japan for Daridorexant (ACT-541468), a Dual Orexin Receptor Antagonist for the Treatment of Insomnia

Retrieved on: 
Tuesday, October 31, 2023

The NDA is supported by positive results of a randomized, double-blind, placebo-controlled Phase 3 study in Japan to investigate the efficacy and safety of daridorexant.

Key Points: 
  • The NDA is supported by positive results of a randomized, double-blind, placebo-controlled Phase 3 study in Japan to investigate the efficacy and safety of daridorexant.
  • The rate of adverse events was comparable between placebo and daridorexant at both treatment doses.
  • Under the agreement, Mochida and Idorsia Japan have jointly developed daridorexant and plan to co-market daridorexant pending Idorsia Japan receiving Japanese PMDA approval.
  • In relation to the filing of this NDA, Sosei Heptares will receive JPY 1.5 billion (US$10 million*).

Mirati Therapeutics Reports Third Quarter 2023 Financial Results and Recent Corporate Updates

Retrieved on: 
Monday, November 6, 2023

SAN DIEGO, Nov. 6, 2023 /PRNewswire/ -- Mirati Therapeutics, Inc. ® (NASDAQ: MRTX), a commercial stage biotechnology company, today announced financial results for the third quarter 2023 along with recent pipeline and corporate updates.

Key Points: 
  • SAN DIEGO, Nov. 6, 2023 /PRNewswire/ -- Mirati Therapeutics, Inc. ® (NASDAQ: MRTX), a commercial stage biotechnology company, today announced financial results for the third quarter 2023 along with recent pipeline and corporate updates.
  • We look forward to continuing our work to improve the lives of people with cancer through Mirati discovered and developed therapeutics."
  • Excluding the August 2023 financing, net decrease in cash, cash equivalents and short-term investments for the third quarter of 2023 was $135.5 million.
  • Net KRAZATI product revenue for the three and nine months ended September 30, 2023 was $16.4 million and $36.1 million, respectively.