Pharma News
07 Jul 2024 to 13 Jul 2024
Jul 12, 2024
Senate passes bill to decrease barriers to competition in the pharmaceutical industry
The U.S. Senate has unanimously passed a pharma patent reform bill aimed at reducing patent thickets and increasing competition in the prescription drug market. The bill will limit the number of patents that pharmaceutical companies can assert in infringement litigations. The legislation also aims to promote generic and biosimilar competition and lower drug prices. The bill was sponsored by Sens. John Cornyn and Richard Blumenthal, and it received support from the Pharmaceutical Care Management Association. However, the bill does not include provisions prohibiting product-hopping.
Jul 12, 2024
Legislation aimed at addressing pharmaceutical 'patent thickets' receives unanimous support in the Senate
The Senate has unanimously passed the Affordable Prescriptions for Patients Act, a bill designed to limit the number of patents drugmakers can assert in litigation on individual biological products, in an attempt to combat "patent thicketing" and promote competition. The bill could result in $1.8 billion in taxpayer savings over a decade. The Pharmaceutical Research and Manufacturers of America (PhRMA) has expressed concerns about the bill, stating that it prohibits innovators from enforcing lawfully granted patents. The bill has been modified since its initial proposal to also tackle the practice of "product hopping".
Jul 12, 2024
Anticipated AbbVie Earnings: What to Look For - TradingView
Pharmaceutical giant AbbVie is set to announce its fiscal Q2 earnings results, with analysts expecting a profit decline of 11.3% from the year-ago quarter. However, the company has surpassed Wall Street's estimates in its last four quarterly reports. The stock has seen fluctuations due to concerns over competition and declining sales of its drug Humira. Analysts have a cautiously optimistic outlook on AbbVie stock, with a consensus rating of "Moderate Buy" and an average price target suggesting a potential upside of 6.9%.
Jul 12, 2024
AbbVie Requests Approval for Rinvoq in Giant Cell Arteritis from US and Europe
AbbVie has filed for expanded approval of its autoimmune drug, Rinvoq, for the treatment of giant cell arteritis. The applications to the FDA and EMA are based on positive results from a Phase 3 study, where Rinvoq achieved sustained remission when combined with a steroid taper regimen. Rinvoq and Skyrizi are expected to help offset the sales decline of Humira for AbbVie.
Jul 12, 2024
Bristol Myers' widely-used leukemia drug prepares to compete with generic alternatives - BioPharma Dive
Bristol Myers Squibb is facing a potential patent cliff as the first generic version of its leukemia drug, Sprycel, is expected to hit the market in September. Sprycel has been a blockbuster drug for the company, reaching $1.9 billion in global sales in 2023. In addition to Sprycel, Bristol Myers also faces generic competition for its drugs Revlimid, Eliquis, and Opdivo in the coming years. The company is focused on expanding its market with CAR-T cell therapy and combination immunotherapies for various types of cancer.
Jul 11, 2024
Novo Nordisk shares drop following FDA rejection of insulin medication
Shares of Novo Nordisk (NYSE:NVO) declined as the FDA rejected the drugmaker's once-weekly insulin product, insulin icodec, for diabetes mellitus. The FDA is requesting more information on the drug's manufacturing process and its efficacy for type 1 diabetes. Novo Nordisk is exploring the FDA's requests but may be unable to provide the necessary information this year. The drug is already approved in several other countries for type 1 and type 2 diabetes. This decision follows concerns raised by an FDA expert panel regarding the drug's benefits versus its risks.
Jul 11, 2024
Pfizer makes progress with weight-loss drug as competition for lucrative market heats up - BNN Bloomberg
Pfizer Inc. announced the successful results of a study on its weight-loss pill, danuglipron. The study tested four formulations of the pill as a once-daily dose, with the aim of finding the most effective formulation. Pfizer did not disclose which formulation worked best but noted that one showed "the most favorable profile." The company plans to move the pill to a mid-stage study in the second half of the year. Some analysts believe Pfizer is buying time to see how another obesity pill it is studying performs.
Jul 11, 2024
Explanation of the misuse of the US pharmaceutical patent system - Chemistry World
The US Federal Trade Commission (FTC) is investigating several pharmaceutical companies, including AbbVie, AstraZeneca, and Teva, over the accuracy and relevance of patents listed in the US Food and Drug Administration's (FDA) Orange Book. The patents, which could be used to delay competition and maintain high drug prices, have prompted calls for reform of the patent system. Strategies employed by pharmaceutical companies include patent evergreening and patent thicketing, which extend exclusivity and delay the entry of generic drugs. Some proposed solutions include a "one and done" system and stronger application of the obviousness doctrine in patent law.
Jul 10, 2024
3 Drug Companies Selling Generic Drugs Worth Monitoring as Market Conditions Improve - Yahoo Finance
The rising volume of generic drugs continues to benefit drugmakers like Amphastar Pharmaceuticals, Teva Pharmaceuticals, and Viatris. These companies are focusing on being the 'first to market' their generic drugs to enjoy market exclusivity and generate profits. They are also implementing cost optimization policies to improve margins and increase efficiency. The generic drug industry faces stiff competition from branded drugs and relies on the loss of patent exclusivity. Settlement of patent challenges and litigation also play a role in the growth of generic drugmakers.
Jul 10, 2024
HEC Faces $50 Million Loss in Gilenya Drug Patent Case After Failed Appeal, Reports Bloomberg Law
Chinese pharmaceutical company HEC Pharm has lost its chance to recover $50 million in a patent dispute over its copy of Novartis' multiple sclerosis drug Gilenya. The failure to appeal the cancellation of a preliminary injunction bond resulted in a federal judge denying HEC's motion for damages. The judge found HEC to have infringed upon US Patent No. 9,187,405, which covers Gilenya's dosage regimen.
Jul 10, 2024
An expert in selecting stocks discovers companies developing potentially groundbreaking treatments
British pharmaceutical companies Scancell, Avacta, Allergy Therapeutics, and OptiBiotix have been identified as potential contenders to produce the next big-selling drug. Scancell is focused on developing a cure for advanced skin cancer using a combination of a vaccine and existing drugs, while Avacta aims to make chemotherapy less toxic for patients. Allergy Therapeutics is working on a vaccine for peanut allergies, and OptiBiotix has developed a product, SlimBiome, to reduce appetite and help with weight loss. These companies could follow in the footsteps of Novo Nordisk, which saw its stock value increase significantly thanks to its weight-loss drug, Ozempic.
Jul 10, 2024
The U.S. government appeals patent decision on Gilead's Truvada and Descovy HIV drugs
Pharmaceutical company, Gilead, has filed an appeal in response to a ruling in a lawsuit brought against them by the U.S. government. The lawsuit claims that Gilead exaggerated its role in the development of HIV prevention drugs, Truvada and Atripla, and ignored patents held by the U.S. government. Gilead recently agreed to pay $40 million to settle over 2,600 lawsuits filed by patients over its HIV drugs, but this appeal does not affect the tens of thousands of lawsuits pending in state court.
Jul 9, 2024
Investors in Ozempic experience significant gains, leading our expert in stock selection to offer insights - This is Money
Shares in Novo Nordisk, the maker of weight-loss drug Ozempic, have surged over the past three years. Other pharmaceutical companies are seeking the next big drug after Ozempic, which is one of the industry's top-selling treatments. British companies, including Scancell, Avacta, Allergy Therapeutics, and OptiBiotix, are all working on potential blockbuster drugs for cancer treatment, peanut allergies, hay fever, and weight loss respectively. While there are no guarantees, the companies have promising treatments that could deliver significant returns for investors.
Jul 9, 2024
The US Government Appeals in Major HIV PrEP Patent Dispute with Gilead
The Biden administration has appealed a 2023 jury decision that found Gilead did not infringe on government patents with its HIV prevention drugs, Truvada and Descovy. The appeal seeks to reverse previous rulings on the invalidity of the patent claims. Gilead has been sued by the Trump administration for profiting from publicly funded research on the drug regimens.
Jul 8, 2024
Report states that Lilly expands its selection of drugs for bowel disease with $3.2 billion Morphic acquisition
Pharmaceutical giant Eli Lilly has agreed to acquire Morphic Holding for $3.2 billion in cash. The deal will give Lilly access to Morphic's experimental oral treatment for inflammatory bowel disease (IBD), expanding its presence in the IBD market. The acquisition follows a series of acquisitions by Lilly in recent years to bolster its drug portfolio.
Jul 8, 2024
Pharma giants in India prepare for obesity pill revolution as patents approach expiration.
India is planning to offer incentives to promote local manufacturing of GLP-1 drugs, used to treat obesity and diabetes, once the patent on Novo Nordisk's semaglutide expires in 2026. The move comes as Indian companies seek to take advantage of the surging popularity of obesity drugs, which have seen a three-fold increase in the market in the past two years. Novo Nordisk's oral semaglutide tablet, Rybelsus, has more than doubled in sales in the past year, reaching INR3.63bn ($49m) in April.
Jul 8, 2024
Caplyta on track to become a blockbuster drug with increasing sales and broader range of uses.
Jefferies analyst Andrew Tsai maintains a Buy rating on Intra-Cellular Therapies (ITCI) stock due to positive Phase III data for its product, Caplyta, a treatment for major depressive disorder. Tsai projects that Caplyta could become a blockbuster with sales reaching $3-4 billion. He also believes that the stock is undervalued and sees a high likelihood of FDA approval. Tsai expects robust sales in the second half of the year and believes that Intra-Cellular Therapies' strategic approach will expand its market reach. RBC Capital also maintains a Buy rating on the stock.
Jul 8, 2024
FDA approves Roche's prefilled syringe version of Vabysmo for easier administration
Roche has received FDA approval to provide its eye disease medication, Vabysmo, in a prefilled syringe. This new option will make it easier for doctors to administer the drug and enhance the treatment experience for both physicians and patients. Vabysmo, which is the only bispecific antibody treatment for the eye, has been gaining market share and is expected to further disrupt the market dominated by Regeneron and Bayer's Eylea.
Jul 8, 2024
The impact of artificial intelligence on transforming the pharmaceutical sector - Nature
biotx.ai, a biotech company, has developed a platform that utilizes causal AI and machine learning to improve predictions of clinical efficacy in drug development. The platform connects drug targets to disease biology and identifies novel candidates with verified causal links to various health conditions. By monitoring biomarker changes in phase 1 clinical trials, researchers can gain early indications of clinical efficacy. This technology aims to revolutionize drug discovery, reduce costs, and improve success rates in clinical trials. Several biotech companies have already utilized biotx.ai's platform and secured funding.
Jul 7, 2024
J&J cautions about potential impact from generic drugs in third quarter, leading to decline in shares.
Johnson & Johnson (J&J) has increased its sales forecast for 2019 due to strong demand for its cancer drugs. However, the pharmaceutical company warned that competition from generic and copycat drugs may impact its third-quarter results. J&J's older drugs have already been affected by cheaper copies, with sales of prostate cancer treatment Zytiga falling 23% and sales of arthritis drug Remicade falling 16%. Despite beating analysts' estimates for sales across all business units, J&J did not raise its full-year earnings forecast. The company also faced litigation charges over its talc products, unrelated to liability payments.
