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FTC Seeks More Information on the $16.5B Novo-Catalent Deal, Leading to Another Delay

Novo Holdings’ $16.5 billion planned acquisition of Catalent is facing another delay. Just weeks after Novo decided to resubmit its application to the FTC, the agency is seeking more information about the deal. This move has triggered a second 30-day delay in the antitrust review process.Novo Holdings’ planned acquisition of Catalent is facing another delay. Just weeks after Novo Holdings decided to resubmit its application to the Federal Trade Commission, the agency is seeking more information about the deal. The transaction was originally expected to close by the end of this year, but this timeline may not be as solid given the repeated delays in the FTC’s review process. The acquisition was announced in early February when Novo Holdings — the investment arm of the foundation that owns a controlling stake in Danish pharma giant Novo Nordisk — disclosed its plans to acquire New Jersey-based contract development manufacturing organization Catalent ...
- Source: drugdu
- 134
- May 8, 2024
FDA Approves Azurity Pharmaceuticals’ Myhibbin as an Oral Suspension for Organ Transplant Recipients

Don Tracy, Associate Editor Myhibbin is reportedly the first FDA-approved liquid formulation of mycophenolate, a key immunosuppressant used to prevent organ rejection in transplant recipients. Axurity Pharmaceuticals announced that the FDA has officially approved Myhibbin as a ready-to-use mycophenolate mofetil oral suspension for organ transplant patients. Myhibbin is the first FDA-approved liquid formulation of mycophenolate, which is used to avoid organ rejection in transplant recipients, according to Azurity. The company stated that this approval provides a significant new option for both pediatric patients above the age of three months and adults who have undergone kidney, heart, or liver transplants.1 “We are very pleased that adult and pediatric organ transplant recipients will soon have access to the only FDA-approved ready-to-use oral liquid formulation of mycophenolate,” said Richard Blackburn, CEO, Azurity Pharmaceuticals, in a press release. “Patients are our priority, and our purpose is to bring them new formulations that help them ...
- Source: drugdu
- 77
- May 8, 2024
Cipla and Glenmark initiate recall of certain products in the US

Cipla and Glenmark Pharmaceuticals are recalling specific products from the US market due to distinct manufacturing issues, the latest Enforcement Report issued by the US Food and Drug Administration (USFDA) noted. The recalls involve inhalation solutions and extended-release capsules used for treating respiratory conditions and high blood pressure, respectively. New Jersey-based subsidiary of Cipla, Cipla USA is recalling 59,244 packs of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution. This product is manufactured at Indore SEZ plant of the company in India. It is prescribed for controlling the symptoms of lung diseases such as chronic bronchitis, asthma, and emphysema. The recall of the affected inhalation solution lot is claimed to be due to complaints of “short fill”. The US regulator detailed that the affected lot was recalled after reports of less fill volume in respules and the presence of a few drops of liquid in the intact pouch. Simultaneously, Glenmark Pharmaceuticals, ...
- Source: drugdu
- 125
- May 8, 2024
Henlius Dual HER2 Blockade Therapy Receives Phase 3 MRCT IND Approval from U.S. FDA

Shanghai, China, May 6, 2024-Shanghai Henlius Biotech, Inc. (2696.HK) announced that the investigational new drug application (IND) for phase 3 international multicenter clinical study of Henlius’ novel anti-HER2 mAb, HLX22, in combination with trastuzumab and chemotherapy for the first-line treatment of HER2-positive advanced gastric cancer has been approved by the United States Food and Drug Administration (FDA). As of now, no similar dual HER2 blockade therapy for the treatment of HER2-positive gastric cancer has received approval for commercialization globally. Until now, gastric/gastroesophageal junction (G/GEJ) cancer still constitutes a major global health problem. Globally, there were around 1 million cases in 2022. G/GEJ cancer generally carries a poor prognosis since it is often diagnosed at an advanced stage, with a 5-year relative survival rate of only 6%. The reported rates of HER2 positivity in patients with gastric cancer range from 12% to 23%, and the prognosis for patients with HER2-positive disease ...
- Source: drugdu
- 71
- May 8, 2024
Nova’s Xromi approved in UK and EU for vaso-occlusive complications of SCD

Nova Laboratories’ Xromi (hydroxycarbamide) has received approval from the Medicines and Healthcare products Regulatory Agency and the European Commission to extend the indication for vaso-occlusive complications of sickle cell disease (SCD) to infants from nine months of age. SCD is a group of inherited red blood cell disorders that are caused by a genetic mutation that affects the production of haemoglobin, the protein in red blood cells that carries oxygen. The regulatory decisions were based on data from the pharmacokinetic, efficacy and safety study, HUPK, which showed that Xromi is expected to work in the same way in children from nine months of age as it does in older children. Furthermore, additional data from the phase 3 BABY HUG study suggests that the benefits and safety of Xromi in children as young as nine months of age are similar to those in older children. Dr James White, deputy managing director, ...
- Source: drugdu
- 82
- May 8, 2024
Study reveals vitamin D-altered mouse gut bacteria provides better cancer immunity

Researchers from the Francis Crick Institute, the National Cancer Institute of the US National Institutes of Health and Aalborg University in Denmark have revealed that vitamin D encourages the growth of a type of gut bacteria in mice, which provides better cancer immunity. The study published in Science found that vitamin D increases the amount of Bacteroides fragilis, providing better immunity to cancer in mice with transplanted tumours. Cancer, including female breast, lung, bowel and prostate cancers, was responsible for more than 18 million new cases worldwide in 2020, according to Cancer Research UK. After giving mice a diet rich in vitamin D, researchers discovered they had better immune resistance to experimentally transplanted cancers and improved responses to immunotherapy treatment. Furthermore, this effect was seen when gene editing was used to remove a protein that binds to vitamin D in the blood and keep it away from tissues. Researchers found ...
- Source: drugdu
- 81
- May 8, 2024
【EXPERT Q&A】What is OTC? What products do FDA need to apply for OTC?

Drugdu.com expert’s response: OTC stands for “Over-the-Counter,” referring to medications that can be purchased without a prescription from a healthcare professional. These medications are typically used to treat common health issues such as headaches, colds, fevers, and mild pains. In the United States, the Food and Drug Administration (FDA) regulates OTC drugs, and certain products require an application for OTC status before they can be sold on the market. Products that need to apply for OTC status according to the FDA include: 1.New Drugs: Drugs that have not been previously marketed require FDA approval before being sold as OTC products, regardless of their composition or effects. 2.Prescription Drugs: Some prescription drugs can apply for OTC status after undergoing clinical studies and safety assessments to demonstrate their safety and effectiveness. 3.Previously OTC Products with Safety Concerns: Certain OTC products may be required by the FDA to halt sales or undergo further ...
- Source: drugdu
- 155
- May 8, 2024
Germany Pharma Expo 2024

Organiser:AVOXA Time:9 – 12 Oct 2024 address：ostfach 10 10 06, D-40001 Dusseldorf Stockum Church Street 61, D-40474, Dusseldorf, Germany- D-40001 Exhibition hall: Dusseldorf Exhibition Center Product range: Medicine: all kinds of drugs, drug wholesale trade, home care products, diagnostics, diagnostic instruments, diet products, health products, cosmetics, pharmaceutical accessories and furnishings, pharmacy DP, pharmacy supplies About Expopharm： German Pharmaceutical Exhibition (Expopharm) 2024, exhibition time: October 09 ~ October 12, 2024, exhibition venue: Dusseldorf, Germany -Stockumer Kirchstraße 61, 40474 Dusseldorf, Germany – Dusseldorf Exhibition Center, Organizer: AVOXA, holding cycle: once a year, exhibition area: 20,000 square meters, visitors: 30000 people, the number of exhibitors and exhibitors brands reached 1500.
- Source: drugdu
- 155
- May 7, 2024
Jacobio Pharma Announced its KRAS G12C inhibitor reached the primary endpoint

BEIJING and SHANGHAI and BOSTON, April 30, 2024 /PRNewswire/ — Jacobio Pharma (1167.HK) announced that the data from the Phase II registrational study of the KRAS G12C inhibitor glecirasib were offically reported at the April ASCO Plenary Series, which was held online. Prof. Yuankai Shi, chief physician of Cancer Hospital Chinese Academy of Medical Sciences, the lead principal investigator of this clinical trial, presented the data in the form of an online oral presentation (Abstract 468214). The efficacy data showed that among second-line non-small cell lung cancer patients receiving monotherapy treatment, the confirmed objective response rate (cORR) was 47.9% (56/117), including 4 patients achieved a complete response (CR) and 36 patients with tumor reduction exceeding 50%. Disease control rate (DCR) was 86.3%. The median progression-free survival (mPFS) was 8.2 months, and median overall survival (mOS) was 13.6 months. The median duration of response (mDoR) has not been reached:6-month and 12-month ...
- Source: drugdu
- 88
- May 6, 2024
Amgen reports a 22% increase in Q1 2024 net revenues

Amgen’s total revenues grew in Q1 2024 to $7.4bn, displaying a 22% increase from earnings reported in the first quarter of last year. The company reported an operating income of $3.1bn, on a non-GAAP [generally accepted accounting principles] basis. The non-GAAP earnings per share (EPS) dipped 1% to $3.96, with the decrease attributed to higher operating and interest expenses that resulted from the acquisition of Horizon Therapeutics. Amgen acquired Horizon for $27.8bn (£22.76bn) following approval from the US Federal Trade Commission (FTC) in October 2023. The revenue growth was driven by a 22% increase in product sales and a 25% volume growth, with ten products achieving double-digit volume growth. Key performers included hyperlipidemia immunotherapy Repatha (evolocumab) and osteoporosis treatment in postmenopausal women Evenity (romosozumab-aqqg), which grew 33% year-over-year (YoY) and 35% YoY respectively in Q1. Amgen also reported an 80% YoY growth for the severe asthma medication Tezspire (tezepelumab-ekko), and ...
- Source: drugdu
- 110
- May 6, 2024

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