Tuesday, July 30, 2024

New Generic Diabetes Drug Shows How Medical Innovation Works

(7/29, Howard Dean, International Business Times) ...The availability of Teva's generic for Novo Nordisk's Victoza ensures that more patients will have access to these state-of-the-art therapies -- and at lower cost. The launch is good for the health of millions of Americans living with type 2 diabetes. It's also a textbook case of how the life sciences industry is supposed to work. Leaps in innovation soon lead to mass-scale availability... Full

8 Drugs Now in Shortage

(7/29, Paige Twenter, Becker's Hospital Review) ...In the second quarter of 2024, there were 300 medications in shortage across the U.S...Bisoprolol fumarate; hydrochlorothiazide tablet: Teva Pharmaceuticals USA discontinued three presentations of the hypertension drug July 26... Full

Torrent On Acquisition And Licensing Strategy, Vonoprazan Trajectory

(7/29, Vibha Ravi, Generics Bulletin) ...Amid deals activity in India, Torrent Pharma executives spelt out their acquisition expectations and licensing strategy while an in-licensed Takeda brand did well in Q1 of FY25. The US growth trajectory is seen determined by five to ten product approvals expected this fiscal... Global Sub. Full

Merck Second Quarter Tops Street View On Strong Keytruda Sales

(7/30, Michael Erman, Reuters) ...Merck & Co posted higher-than-expected second-quarter results on Tuesday on strong growth of its blockbuster cancer immunotherapy Keytruda, the world's best-selling prescription medicine...Sales of Keytruda, which is approved to treat many types of cancer, hit $7.3 billion for the quarter, up 16% from a year ago. Analysts had expected sales of around $7.1 billion. Merck said it now expects full-year sales of $63.4 to $64.4 billion, up from its prior view of $63.1 to $64.3 billion. Analysts have forecast 2024 sales of $64.3 billion... Full

Pfizer Raises Annual Profit Forecast After Better-Than-Expected COVID Sales

(7/30, Bhanvi Satija and Christy Santhosh, Reuters) ...With the pandemic becoming less severe, the market for pharmaceutical products used in managing COVID-19 has quickly disappeared, eroding billions of dollars in sales of vaccines and treatments for companies such as Pfizer. Pfizer said it was now expecting full-year revenue of $8.5 billion from its Comirnaty and Paxlovid vaccines, up from its previous expectation of about $8 billion... Full

Granules India's Q1 Profit Nearly Triples On Strong Demand

(7/30, Kashish Tandon, Reuters) ...Granules India reported a surge in first-quarter profit on Tuesday, helped by strong demand in the European and North American markets...Granules, which holds a 30% share of the global paracetamol market, sells the drug as an API and finished dosage - ready for consumption product - in Europe as well as in Canada and South Africa. APIs are the active elements in a drug which are responsible for the desired health effects. Paracetamol is a significant contributor to Granules' total revenue... Full

Strides Pharma Reports Profit of Rs 68.3 Crore in Q1, Revenue Up 16%

(7/29, Aneeka Chatterjee, Business Standard) ...Bengaluru-based pharmaceutical company Strides Pharma Science on Monday reported a net profit of Rs 68.3 crore in the first quarter of 2024-25 (Q1FY25). The firm had reported a loss of Rs 9.4 crore in the same quarter of the previous financial year (Q1FY4)... Full

WuXi AppTec Sees US Revenue Decline Amid Biosecure Threat

(7/29, Amber Tong, Endpoints News) ...Despite the 1.2% decline, the US remains the biggest source of WuXi AppTec's revenue, accounting for RMB $10.71 billion ($1.48 billion) over six months — or 62% of total revenue. The contract research, development and manufacturing giant reported growth in both China and Europe, while recording lower revenue in Japan, Korea and other regions... Full

Formycon Announces Start of Clinical Phase III Trial for Keytruda® Biosimilar Candidate FYB206

(7/30, Formycon AG) ..."Immuno-oncology is a relatively young field in cancer therapy and is seen as a great hope for many patients. Pembrolizumab has already demonstrated its efficacy in numerous types of cancer. Additionally, several studies are currently underway to expand the range of indications. This alone highlights the enormous potential of our pembrolizumab biosimilar candidate FYB206 – both in medical and economic terms. In fact, sales of Keytruda®, currently the world's best-selling drug, are also continuing to grow. The start of the Phase III clinical trial represents an important milestone for us in order to provide an effective, safe and cost-effective treatment option for many severely ill cancer patients worldwide in the future," comments Dr. Andreas Seidl, Chief Scientific Officer of Formycon AG... Full

AstraZeneca Trumpets New Calquence Combos in CLL. Can They Change Clinical Practice?

(7/29, Angus Liu, Fierce Pharma) ...Monday, AZ said its BTK drug Calquence, used in combination with venetoclax—both with or without Roche's Gazyva—outperformed traditional chemoimmunotherapy at staving off tumor progression or death in patients with previously untreated CLL. The trial's positive top-line results come from an interim analysis of the phase 3 AMPLIFY trial. Previously, AZ anticipated a readout from the trial to come in the second half of 2025. An AZ spokesperson confirmed to Fierce Pharma that the doublet and the triplet regimens met their progression-free survival goals separately under the trial design... Full

European Medicines Agency (EMA) Approves Bio-Thera Solutions' BAT1706 (Avzivi®, Bevacizumab), a Biosimilar Referencing Avastin

(7/30, Bio-Thera Solutions Inc.) ...Bio-Thera Solutions Inc., a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that the EMA has approved BAT1706 (bevacizumab), a biosimilar referencing Avastin®. Sandoz AG and its affiliates have rights to market BAT1706 in Europe under the brand name Avzivi®. BAT1706 is Bio-Thera's second EMA approved product and Bio-Thera's second product to receive marketing authorization from NMPA, US FDA and EMA... Full

FDA Approves Benzgalantamine for Treatment of Alzheimer Disease

(7/29, Ashley Gallagher, Pharmacy Times) ...The FDA has approved benzgalantamine (Zunveyl; Alpha Cognition), a cholinesterase inhibitor, to treat mild-to-moderate dementia associated with Alzheimer disease in adults. The novel oral therapy is designed to eliminate drug absorption in the gastrointestinal tract, which addresses tolerability concerns associated with other AD medications...The company expects the drug to be available by prescription starting in the first quarter of 2025... Full

GSK Becomes Flagship's Latest Partner in $7B Biobucks Respiratory, Immunology Pact

(7/29, James Waldron, Fierce Biotech) ...The British drugmaker and the venture creation firm will put a combined $150 million upfront towards a respiratory and immunology-focused research project, which will involve Flagship's portfolio of over 40 biopharma companies. The goal is to identity up to 10 novel medicines and vaccines, for which GSK will have an exclusive option to take forward for further clinical development... Full

With New CDC Recommendations, RSV Market's Long-Term Value Falls Sharply in US: Airfinity

(7/29, Kevin Dunleavy, Fierce Pharma) ...A month after a CDC panel narrowed its recommendations for who should receive vaccines to protect against respiratory syncytial virus, Airfinity has put numbers to the impact, reducing the projected market value in the United States by 64% by the end of the decade. The London-based healthcare analytics company has sliced the RSV market value for seniors in the US from $4.7 billion to $1.7 billion in 2030... Full

Amneal Pharmaceuticals Gets Additional FDA New Drug Application Approval

(7/29, Sabela Ojea, Dow Jones) ...Amneal Pharmaceuticals said the U.S. Food and Drug Administration approved its new drug application for its potassium phosphates in sodium chloride injection, available as a single-dose infusion bag... Full

Boehringer Ingelheim Buys Oncology Biotech for Up to $1.3B

(7/29, Kyle LaHucik, Endpoints News) ...The German drug giant said Monday morning it will buy preclinical-stage Nerio Therapeutics to get a small molecule that inhibits protein tyrosine phosphatases N1 and N2, or PTPN1 and PTPN2. The goal is to inhibit the immune checkpoints to destroy cancer cells. AbbVie and its partner Calico are working on PTPN2 inhibitors as well, with ABBV-CLS-484 and ABBV-CLS-579 in early clinical testing... Full

USFDA Scrutiny Delays Generic Drug Approvals for Major Indian Pharma Firms

(7/30, Vasudha Mukherjee, Business Standard) ...Regulatory scrutiny by the US Food and Drug Administration has significantly impacted the approval rate of new drugs from major Indian pharmaceutical companies in the first quarter of the financial year 2024-25 (FY25)...Despite the regulatory hurdles, the US business for most companies is expected to grow by 2-4 per cent quarter-on-quarter and around 8 per cent year-on-year, driven by stable pricing and new product launches... Full

With Multi-State Agreement Worth $86M, Indivior Moves to Resolve More Opioid Litigation

(7/29, Zoey Becker, Fierce Pharma) ...Suboxone maker Indivior has spent years dealing with allegations related to its role in the United States opioid epidemic, inking several settlements over that span and even witnessing its former CEO land a six-month prison term. In the latest deal, the company agreed to a deal in principal to pay up to $86 million to participating states over five years... Full

Indivior Reaches $86M Settlement Over its Alleged Role in the Opioid Epidemic

(7/29, Katherine Lewin, Endpoints News) ...Virginia-based Indivior sold buprenorphine-based products that are designed to treat opioid use disorder but can also worsen an opioid addiction when abused, according to James, who accused the company of targeting sales to "dangerous prescribers" and not monitoring suspicious orders of its drugs. "As a result of our work to hold Indivior accountable, they will end their destructive practices and provide new resources to invest in opioid addiction treatment, prevention, and education that will help save lives in New York," James wrote in a statement... Full

AG Nessel Announces $1.2 Billion Settlement with Kroger for Role in Opioid Epidemic, Calls On Local Units to Participate

(7/29, Michigan Attorney General Dana Nessel) ...Michigan Attorney General Dana Nessel is encouraging municipalities to join a $1.2 billion national settlement with Kroger to resolve allegations that the company contributed to the opioid epidemic. Michigan governments will receive nearly $42 million from the settlement over 11 years to help address the opioid crisis... Full

Ustekinumab Dawns: Surveying The Biosimilar Landscape For IBD

(7/29, Dean Rudge, Generics Bulletin) ...Biologic treatments for inflammatory bowel disease, Crohn's disease and ulcerative colitis, are growing apace in Europe, buoyed by biosimilar competition for the first wave of treatments like infliximab and adalimumab. Generics Bulletin looks at what is on the horizon in the growing, multi-billion-dollar IBD space... Global Sub. Full

Vizient Projects Drug Price Inflation at 3.81%

(7/30, Vizient, Inc.) ...Vizient, Inc. released its summer Pharmacy Market Outlook estimating the 2025 overall drug price inflation rate for pharmaceuticals at 3.81% based in part on expanding indications of previously approved medications, such as semaglutide, which increased 77% in spend since the summer 2023 Outlook. The report also urges providers to prepare for an increased number of high-cost cell and gene therapies entering the market that will significantly impact provider budgets and operational processes. View the summer 2024 Pharmacy Market Outlook... Full

In the Specialty Drug Spend, Biologics Rule

(7/29, Peter Wehrwein, Managed Healthcare Executive) ...Although there is some shuffling among the rankings among them, 9 of the top 10 drugs by expenditure in 2023 were biologics, according to the report, which is based on datafrom PSG clients that allow their data to be used for research and benchmarking purposes. The lone exception is Trikafta, a drug used to treat cystic fibrosis that consists of three related small molecules: elexacaftor, tezacaftor, ivacaftor... Full

Pharma Companies Less Concerned After Hearing from US On Negotiated Prices for Medicare

(7/29, Patrick Wingrove and Michael Erman, Reuters) ...Four pharmaceutical companies involved in the first U.S. negotiations over prices for the Medicare program said they do not expect a significant impact on their businesses after seeing confidential suggested prices from the government for their drugs that will take effect in 2026. Top executives from Bristol Myers Squibb, Johnson & Johnson, AbbVie and AstraZeneca, which have five of the 10 drugs chosen for the first wave of negotiations, described their newly informed views on quarterly conference calls..."I think the drugmakers were frightened (these prices) would be a big deal. But now, the ones who have reported or commented have actually said it seems to be OK and in line with expectations," UBS analyst Trung Huynh said in an interview... Full

Patients Push Back Against Novo Nordisk Move to Scrap An Insulin Product

(7/30, Maggie Fick, Ahmed Aboulenein, Reuters) ...Novo Nordisk's decision to stop selling its long-acting insulin Levemir in the United States has left some diabetes patients struggling to switch treatments, patients and doctors in a dozen U.S. states told Reuters...A new group of parents and patients, called the Alliance to Protect Insulin Choice, have taken their Levemir concern to Capitol Hill. Their petition urging Novo Nordisk to continue making Levemir has garnered over 4,000 signatures, said Alison Smart, one of the parents who set up the group... Full

How to Tell if Biden Drove a Hard Bargain On Drug Prices

(7/30, John Wilkerson, STAT) ...The deadline for announcing how much Medicare lowered drug prices in the first year of negotiation is Sept. 1, just ahead of U.S. elections...The law lays out a detailed process, including choosing which drugs are subject to negotiation, government offers, and industry counteroffers. The negotiated prices for those drugs take effect at the beginning of 2026, but the release of the prices is a significant milestone. "After all of this, what does success look like?" asked Peter Neumann, a professor of medicine at Tufts University...This article will focus on ways to evaluate that question for two of the 10 drugs chosen for negotiation: Eliquis and Xarelto, which are both used to prevent blood clots... Full

Medicare Prepares for Changes in Drug Premiums, Coverage

(7/29, Tony Pugh, Bloomberg Law) ...The average monthly beneficiary premium for Medicare prescription drug coverage is expected to be $36.78 next year, or $2.08 more than in 2024, the Biden administration announced Monday. Preliminary Part D bid information released Monday is meant to help Medicare Part D drug plan sponsors finalize their prescription drug and Medicare Advantage offerings and prepare for Medicare open enrollment at the end of the year... Paid Sub. Req'd

Democratic Congressional Candidates, Including Maryland's, Show Support for Caps On Health Care Costs

(7/30, Hannah Gaskill, The Baltimore Sun) ...Each Democratic nominee vying for a congressional seat in Maryland has pledged their support to upholding the measures that would benefit Zarzecki and millions of other patients struggling with the cost of lifesaving care by capping out-of-pocket costs for prescriptions at $2,000 each year. The sweeping Inflation Reduction Act, or IRA, passed without support from any Republicans in 2022. Advocates are concerned about the future of health care cost-saving measures in the IRA should Republicans take control of Congress or the White House... Full

Another Investigation Revealing Monopolistic PBM Behavior Receives Industry's Support

(7/30, Urte Fultinaviciute, Generics Bulletin) ...While a recent FTC probe revealed PBM practices that block access to generics and biosimilars, a new report by the US House Committee shows that the three big PBMs may seek a safe harbor in foreign countries to avoid scrutiny...Despite PBMs being the "best positioned entities to decrease the cost of prescription drugs," since they control 80% of the market and have vertically integrated businesses, the House Committee argued that the opposite has happened and patients "are seeing significantly higher costs with fewer choices and worse care."... Global Sub. Full

Editorial: Pharmacy Benefit Managers Shouldn't Have Free Rein to Drive Up Drug Prices

(7/30, The Boston Globe) ...Passing provisions immediately to bring PBMs under the Health Policy Commission's jurisdiction and creating a state licensing scheme will give lawmakers the opportunity to gather the necessary information to determine what additional policies make sense. PBMs have potential to drive drug prices down and save consumers money. They shouldn't be allowed to do the exact opposite... Full

The FTC's Villains du Jour Are the Pharmacy Benefit Managers

(7/30, Ike Brannon, RealClearMarkets) ...The Inflation Reduction Act of 2022 was epochal in that--for the first time ever– it gave the federal government the power to negotiate the price of certain prescription drugs with the pharmaceutical companies. This unprecedented step created a conundrum for politicians: If people still perceive that drug prices are too high after the government starts setting prices, and Big Pharma isn't to blame, they might blame the politicians. To escape this potential own-goal, the Biden Administration has declared a new villain in the drug market: the middlemen, or what we call pharmacy benefit managers... Full

Draft Guidance On Biosimilars and Interchangeables Tries to Smooth Path for Post-Approval Changes

(7/30, John W.M. Claud, FDA Law Blog) ...There is a growing consensus among legal experts that after Loper Bright, FDA may rely on non-binding guidance to instruct industry with hopes of charting regulatory pathways that avoid litigation. In areas like biologics, biosimilars, and interchangeable biosimilars, where emerging technologies meet regulatory complexities, this is perhaps a wise strategy... Full

Could Texas Save Money by Giving Free Ozempic to Diabetes Patients?

(7/29, Aaron Nelsen, Texas Monthly) ...So, given the high costs of diabetes care, could health systems and insurers save money by making GLP-1 medications available for free, or at exceedingly low costs, to all patients with the condition or at risk of developing it? Three economists from the Massachusetts Institute of Technology and Stanford sought to answer that question. They crunched the numbers on providing Ozempic for free to all Americans with obesity, a chronic disease linked to a host of health issues, as well as 53 percent of new cases of type 2 diabetes each year... Full

Prescription Shortages Can Add to Prices and Frustration

(7/30, Keith Dean, Tallahassee Democrat) ...Prescriptions are intended to improve how people feel - not make them feel worse. Pharmaceutical companies need to keep that in mind when they are setting drug prices and managing the supply chain. Shortages shouldn't occur because of financial choices that are made at the expense of patients... Full

National Drugstore Has Shut Most of its Stores in Ohio and Michigan - Bringing the Total Since Announcing Bankruptcy to Nearly 800 Across US

(7/30, James Cirrone, Daily Mail) ...Rite Aid has now closed 772 stores since October 2023, representing over a third of the roughly 2,000 locations it operated before it fell into bankruptcy. Michigan and Ohio are the worst hit - with an astonishing three in four Rite Aids in the two states now shut...Drugstores, generally, are struggling to compete with big-box chains and with Amazon, which launched its own online-only pharmacy in 2020... Full

Swissmedic Survey Finds Drug Approval Timelines Slower Than EMA, FDA

(7/29, Ferdous Al-Faruque, Regulatory Focus) ...A new study by Swissmedic shows that it takes significantly more time to authorize new drugs in Switzerland than in the EU or US, and the gap is growing compared to the agency's previous report...Swiss regulators found that, on average, their NA NAS standard procedure throughput times took 15% longer in 2023 compared to 2022. This trend was more pronounced for orphan drugs, which took 72% longer to review... Full

EMA Makes A Case For Focused Guidance On Nasal Products

(7/29, Vibha Sharma, Pink Sheet) ...The European Medicines Agency has identified the need for a guideline specifically on therapeutic equivalence for nasal medicinal products. The new nasal products guideline will draw inferences from the EMA's existing guideline on orally inhaled products. TE data requirements for nasal products will vary depending on the intended site of action of the active substance (ie, whether the effect is locally or systemically mediated)... Paid Sub. Req'd

Bring State and Pharma Together to Solve Greek Access Woes, Says Trade Group

(7/29, The Pharma Letter) ...According to the Patients W.A.I.T. Indicator 2023 from the European Federation of Pharmaceutical Industries and Associations and IQVIA, less pharma innovation is now reaching Greek patients, with 79 out of 167 new drugs coming to Greece between 2019 and 2022, compared to 90 out of 168 in 2018 to 2021. For these medicines, it takes an average of 587 days from their European approval until they are reimbursed in Greece. This is almost two months below the European average, but has improved by 74 days compared to the previous period... Paid Sub. Req'd

EMA Supports Pilot for Joint African Continental Assessment Procedures

(7/30, European Medicines Agency) ...EMA has awarded a grant to the African Medicines Regulatory Harmonisation (AMRH) initiative of the African Union Development Agency (AUDA-NEPAD) to support a pilot to test procedures for the joint continental evaluation of medicines in Africa... Full

Australia Prioritizes GMP-Compliant Manufacturers For Shorter Inspections

(7/29, Ian Schofield, Pink Sheet) ...Australia's Therapeutic Goods Administration is to begin carrying out shorter good manufacturing practice "surveillance inspections" in an effort to tackle the backlog of inspections that built up as a result of the COVID-19 pandemic. The new risk-based arrangements, which are expected to be in place for up to two years, will apply to inspections of selected domestic and overseas manufacturers of medicines, active pharmaceutical ingredients, biologicals and blood products... Paid Sub. Req'd

Egypt Pioneering Biosimilar Adoption in Middle East, Africa: Act4Biosimilars

(7/29, Daily News Egypt) ...Egypt is emerging as a leader in the adoption of biosimilar medicines in the Middle East and Africa (MEA), according to a new report by Act4Biosimilars. The global initiative, founded and sponsored by Sandoz, released its Deep Dive Report for the MEA region, highlighting the challenges and opportunities in biosimilar adoption. Egypt, among other countries, is identified as a key market with the potential to significantly increase access to life-saving treatments... Full

Govt Plans Regulatory Crackdown On Similar-Sounding, Look-Alike Drug Brands

(7/30, Rimjhim Singh, Business Standard) ...The Centre aims to enhance patient safety and reduce the risks associated with look-alike sound-alike drugs. The Centre is likely to recognise only the original brand names approved by the regulator. Any subsequent brands with identical or similar names and appearances will be prohibited from being marketed. Drug manufacturers will soon be required to upload their product formulations and brand names on the government's portal, the report said... Full

Japan Unveils Plan to Improve Access to Foreign Drugs

(7/30, Yukana Inoue, The Japan Times) ...Japan on Tuesday released a road map seeking to address the unavailability of foreign drugs in the country due to complicated approval processes, with development of in-demand medicines planned to start by April 2026. The road map to address what is known as "drug loss" also envisions the establishment of more than 10 pharmaceutical startups by 2028 through the doubling of investment by that point... Full

Editorial: Shortage of Generic Drugs: Review Small-Volume, Multiproduct Manufacturing Structure

(7/29, The Yomiuri Shimbun) ...Commonly used generic drugs such as cough medicines are constantly in short supply. This situation is occurring mainly because many generic drug manufacturers are small and midsize companies that are only able to produce small volumes of a wide variety of medicines...With generic drugmakers lacking sufficient capacity to cope with a sudden increase in production, 30% of generic drugs are currently in short supply... Full

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