Friday, August 9, 2024

PTT Completes the Acquisition of Innovative Medicine Developer and Manufacturer ‘Teva Pharma Thailand'

(8/8, Kaohoon International) ...PTT Public Company Limitedhas announced that the company has completed the acquisition of Teva Pharma (Thailand) with a transaction value of THB 1,650 million to emerge as a leading pharmaceutical business in Southeast Asia... Full

Sandoz Shuffles Management And Sets Out Restructuring Plans

(8/8, David Wallace, Generics Bulletin) ...Speaking as Sandoz delivered its second-quarter results, CEO Richard Saynor also offered details of a restructuring plan that would drive efficiencies for the company. Since its spinoff from former parent company Novartis last October, "we've been working hard in transforming our organization to become a more fit-for-purpose, more agile, simpler and more efficient organization," Saynor explained...The firm said its generics business that brought in sales of $1.8bn in Q2 had seen momentum from the international region, with Europe remaining "stable despite strong prior year comparisons," including "strong sales of apixaban in the first half of 2023 which was withdrawn in the Netherlands following a court decision in August 2023, and an exceptional cough and cold season last year."... Global Sub. Full

Generic Weight-Loss Drugs? They're Coming - Eventually, Executive Says

(8/8, Steve Goldstein, Dow Jones) ...Sandoz, the generics drugmaker spun off from Novartis, is going to get into making cheap versions of the wildly popular GLP-1 class of drugs to treat diabetes and weight loss. But it may take a while. That's based on remarks Remco Steenbergen, Sandoz's chief financial officer, made on a conference call on Thursday..."The first wave of GLP-1s coming off patent really starting [in] Canada in 2026 with semaglutide and then a number of the international markets for the diabetes indication. So you won't see a big step-up there," he said, according to a transcript from S&P Global Market Intelligence... Full

Amneal Pharmaceuticals Lifts FY Outlook After 2Q Revenue Soars

(8/9, Dean Seal, Dow Jones) ...Amneal Pharmaceuticals raised full-year guidance after strong demand for generics and specialty products lifted revenue in the second quarter...Generics revenue jumped 14% on strength in biosimilars and new product launches, while specialty revenue was up 7%, driven by the company's promoted neurology and endocrinology products. The AvKARE brand in Amneal's portfolio saw revenue rise by a third, with strength across its sales channels... Full

Viagra-Maker Viatris Beats Q2 Estimates On Branded and Generic Drug Demand

(8/8, Puyaan Singh, Reuters) ...Drugmaker Viatris beat second-quarter profit and revenue estimates on Thursday, driven by strong demand for the Viagra-maker's off-patent branded and generic drugs...The Canonsburg, Pennsylvania-based company also raised the 2024 sales outlook for its new product range, including Breyna - a biosimilar to Astrazeneca's asthma drug Symbicort - to between $500 million and $600 million, up from its previous range of $450 million to $550 million... Full

India's Biocon Posts Q1 Profit Rise On Sale of Branded Formulations Business

(8/8, Rishika Sadam, Reuters) ...Biopharmaceutical company Biocon Ltd reported a more than six-fold rise in first-quarter profit on Thursday, boosted by a one-time gain from the sale of its Indian branded formulations business...The company's quarterly profit was also boosted by the increased market share of its biosimilars, which include treatments for cancer, diabetes and immunology-related conditions... Full

Biocon Eyes Biosimilars Business Expansion With Launch Of New Products In US, Europe

(8/9, NDTV Profit) ...Biocon Ltd. is hopeful of expanding its presence in the biosimilars segment on the back of new product launches in the long run, according to Group Chief Executive Officer Peter Bains. Biosimilars, the largest business of the Biocon Group, posted 11% year-on-year revenue growth in the first quarter of fiscal 2025 on a like-for-like basis. The company will be able to maintain this growth trajectory and even expand with the launches of new products in the American and European markets in the next two to three years, Bains said... Full

India's J B Chemicals and Pharma Tops Q1 Profit View On Domestic Business Strength

(8/8, Hritam Mukherjee, Reuters) ...This is Mumbai-based J B Chemicals' eighth straight quarter of higher profit. The company, which makes acid reflux drug 'Rantac', continues to benefit from buoyant demand for its copycat drugs, such as antibiotic drug 'Metrogyl', and lozenges for sore throats. New launches across its portfolio are expected to further spur growth for the domestic business, analysts said. The share of the domestic business in overall revenue has been growing and stood at 54% for fiscal year 2024... Full

India's Zydus Lifesciences Q1 Profit Beats Estimates On Strong US Demand

(8/9, Kashish Tandon, Reuters) ...Indian drugmaker Zydus Lifesciences reported a bigger-than-expected first-quarter profit on Friday, driven by strong demand for its generic respiratory drugs in its key market of North America...Alembic Pharma's profit for the quarter also rose, led by strong U.S. sales. However, these drugmakers have been grappling with price erosion in the market amid stiff competition... Full

Zydus Lifesciences Hits All Time High On USFDA Nod for Drug Worth $2 Bn

(8/9, Business Standard) ...Zydus Lifesciences stock surged as much as 2.61 per cent, hitting its all time high at Rs 1313.05 per share on the BSE in Friday's intraday deals. The stock price surged after the company received final approval from the United States Food and Drug Administration to market Valbenazine capsules in the dosage of 40 mg, 60 mg, and 80 mg. The drug is a generic equivalent of US reference listed drug Ingrezza capsules... Full

Amneal Pharma's Extended-Release Parkison's Treatment Clinches FDA Approval

(8/8, Katherine Lewin, Endpoints News) ...Compared to an immediate-release formulation, Amneal said that its treatment demonstrated a statistically significant improvement of 0.5 hours of additional "Good On" time per day, with an average of three times a day dosing with Amneal's drug compared to five times a day dosing with the immediate-release option. The most common adverse reactions were anxiety and nausea... Full

WuXi Bio Gains Some Traction in Europe in the Face of Biosecure Threat in the US

(8/8, Anna Brown, Endpoints News) ...On Thursday, the German biotech Medigene said it had signed a multi-year agreement with WuXi Bio to design a type of T cell engager for cancer. Medigene's public announcement is a rarity ever since the Biosecure Act started gaining momentum in February this year..."To our knowledge, WuXi Biologics has not, does not and will not pose any national security risk to the US or any other country," a Medigene spokesperson told Endpoints News in an email. WuXi Biologics has hit back against allegations of having military ties and said the acquisition was misleading... Full

FDA Approves Citius Pharma's Non-Hodgkin Lymphoma Drug Lymphir

(8/8, Katherine Lewin, Endpoints News) ...Citius Pharmaceuticals scored an approval from the FDA on Thursday for its treatment for a rare form of non-Hodgkin lymphoma, bringing to the market a reformulation of a cancer immunotherapy that was previously approved but later withdrawn...In a Thursday interview, Citius CEO Leonard Mazur told Endpoints News it was a delay in a manufacturing test that caused the CRL: The company passed the test, but the validation procedure was going to run past the PDUFA date last year... Full

Celltrion's Zymfentra Secures Inclusion in 26 US Formularies

(8/9, Kim Ji-hye, Korea Biomedical Review) ...Celltrion's Zymfentra, the first and only subcutaneous infliximab therapy worldwide, also known as Remsima SC outside the U.S., is moving rapidly to become a global blockbuster, the company said Friday. In just five months of its U.S. launch this past March, Zymfentra has been listed on 26 formularies, including those managed by the country's leading pharmacy benefit managers and insurers, it added... Full

Eli Lilly Lifts Sales Guidance by $3B as Supplies of Mounjaro and Zepbound Recover

(8/8, Fraiser Kansteiner, Fierce Pharma) ...Lilly, which reported a 36% year-over-year sales increase to $11.3 billion in the second quarter, is raising its guidance for the full year by a staggering $3 billion. All told, the company now expects to rake in sales between $45.5 billion and $46.6 billion in 2024, according to a Thursday release. Lilly says it's raising its outlook thanks to the strong performance of its dual GIP/GLP-1 meds for diabetes and obesity, Mounjaro and Zepbound—though the company's suite of non-incretin medicines is expected to chip in, too... Full

Lilly Says to ‘Take Some Caution' On Other Companies' Early-Stage Obesity Data, Calls Out Compounders

(8/8, Kyle LaHucik, Endpoints News) ...On Thursday's conference call with investors, Chief Scientific Officer Dan Skovronsky responded to questions about Lilly's future competitors, who have been releasing promising early and mid-stage data that have shown signs of being able to compete. "I know investors have gotten excited about various releases of Phase 1 data, but it's still a challenging space to develop drugs, and we usually wait until we've seen pretty robust Phase 2 data before we get too excited about a particular molecule," Skovronsky said... Full

Lek Pharmaceuticals' Biosimilar Production Facility, Lendava, Slovenia

(8/7, Pharmaceutical Technology) ...Lek Pharmaceuticals, a subsidiary of Sandoz Pharmaceuticals, has initiated the construction of a new high-tech biopharmaceutical production centre in Lendava, Slovenia, to expand its biosimilar production capabilities. The new facility is the first among three planned for the Lek site in Lendava. It will generate energy products for existing production and support a future centre for producing drug substances for biosimilars, targeting treatments in rheumatology, oncology and immunology... Full

Developers of Vapes for Migraine, Asthma will Need to Win Over Sceptics

(8/9, Emma Rumney, Reuters) ...A handful of North American companies which see potential for vape-like devices to ease migraines and respiratory diseases such as asthma have a long road to convince health authorities and patients that their products can be the future of inhaled medication. Two companies, Qnovia and MIIST Therapeutics, have developed vape-like devices based on technology used in existing medical nebulisers, which turns liquid medications into a fine mist... Full

Mark Cuban's Company Shifts From Partner To ‘Consultant' In Amazon-Blue Shield Pharmacy Venture

(8/8, Bruce Japsen, Forbes) ...The role of Mark Cuban Cost Plus Drug Company has changed a year after Blue Shield of California a year ago announced the prescription management model that also includes Amazon, a pharmacy benefit venture owned by Blue Cross and Blue Shield plans called Prime Therapeutics, and Abarca Health, a pharmacy benefit and services firm...Now, Blue Shield of California says it expects Cuban's Cost Plus Drug Company to be "part of our pharmacy network" for its members when the model launches on January 1, 2025... Sub. Req'd

US Chamber Faces Second Loss in Case to Block US Drug Price Plan

(8/8, Nyah Phengsitthy, Bloomberg Law) ...Judge Michael J. Newman of the US District Court for the Southern District of Ohio dismissed a lawsuit filed by the US Chamber of Commerce and its affiliates because they do not have associational standing to challenge the constitutionality of the Medicare Drug Price Negotiation Program... Sub. Req'd

Ohio Business Groups' Challenge to US Drug Price Negotiation Program Dismissed

(8/8, Brendan Pierson, Reuters) ...The judge found that the U.S. Chamber of Commerce, also a plaintiff in the case, did have standing to bring claims on behalf of its members over nationwide issues like the drug pricing law, since its purpose is to represent business interests nationwide. However, he said, it had no reason to bring its case in Ohio and so must be dismissed as well... Full

Federal Court Tosses Chamber of Commerce's Medicare Negotiation Challenge

(8/8, Joseph Choi, The Hill) ..."Plaintiffs have provided no information — in their amended complaint or otherwise — directly connecting the interests of Pharmacyclics or AbbVie to the business climate in the Dayton area," Newman wrote in explaining why he believed three of the plaintiffs lacked standing..."We are carefully reviewing the court's ruling and considering next steps. We support access to affordable health care," a Chamber spokesperson said in a statement to The Hill... Full

Q&A: PhRMA CEO Stephen Ubl On the IRA, Challenges to the FDA's Authority and the US-China Relationship

(8/8, Nicole DeFeudis, Endpoints News) ...Endpoints News spoke to Ubl over a half-hour at PhRMA's office in Washington. In the wide-ranging conversation, the relentlessly-on-message trade group leader answered questions on Medicare price negotiations and the legal fight against the IRA, US tensions with China, the importance of "scientific independence" for the FDA, and the impact of a Trump or Harris administration on the industry... Full

Payers to Increase Utilization Management if the IRA Leads to Higher Costs

(8/8, Denise Myshko, Formulary Watch) ...Payers are considering several changes to their Medicare plans for 2025 and 2026 to address rising costs they expect to result from the Inflation Reduction Act (IRA). These include favoring more generics and biosimilars, increasing use of prior authorizations for Part B products, and scaling back enhanced benefits, according to a new survey by Magnolia Market Access, a market research consultant for pharmaceutical companies... Full

Medicare Paid Substantially More for J&J's Stelara When it Was Covered Under Part D Than Under Part B

(8/9, Ed Silverman, STAT Plus) ...We asked the Centers for Medicare and Medicaid Services about the rationale for the MAC coverage decision and will pass along any reply. The change in coverage by the MACs will be explored in still another report later this year, according to an OIG Regional Inspector General David Tawes. The increased spending led HHS to select Stelara as one of 10 drugs covered under Part D without generic or biosimilar competition for the first cycle of Medicare drug price negotiations. However, over the past several months, the Food and Drug Administration approved the first biosimilar versions of Stelara, which means the J&J drug may not be subject to price negotiations, the OIG noted... Sub. Req'd

Democrats Call On Administration to Enforce ‘March-In Rights' to Counter High Drug Prices

(8/8, Joseph Choi, The Hill) ...A trio of lawmakers who caucus as Democrats are calling on the Biden administration to bolster and finalize a federal rule utilizing the government's legal authority to seize taxpayer-funded patents in order to combat the high price of drugs, despite Republicans arguing recent Supreme Court rulings supersede such powers...The Democratic lawmakers wrote to Becerra and Raimondo that their agencies retained the authority to relicense a drug patent if the drug is "not available to the public on reasonable terms."... Full

Slotkin Pushes to Strengthen Pharmaceutical Supply Chain with Bipartisan Legislation

(8/8, Congresswoman Elissa Slotkin) ...U.S. Rep. Elissa Slotkin (MI-07) – a cofounder of the bipartisan Domestic Pharmaceutical Manufacturing Caucus – introduced this week bipartisan legislation to encourage U.S. manufacturing of critical pharmaceuticals and reduce dependence on foreign sources. The Michigan Hospital Association endorses the legislation. The American Made Pharmaceuticals Act would incentivize domestic production of critical medicines and help prevent drug shortages by securing the pharmaceutical supply chain... Full

Combating Drug Shortages Requires Multifaceted Approach

(8/8, Bruce A. Scott, MD, AMA) ...Drug shortages harm patients and the physicians who care for them, and must be addressed by regulators and policymakers. This reform should begin with far greater transparency of the drug supply chain and all those who operate within it. The AMA remains committed to working cooperatively with all stakeholders to put this critical public health problem behind us... Full

First Generic Approvals

(8/8, Bob Pollock, Lachman Consultants) ...As you see, the numbers of first generic approvals are consistent, going from 72 to 107, as would be expected based on a number of variables, some of which are outlined above. The number is also highly influenced by the number of New Drug Applications (NDAs) approved for different entities. Kind of obvious but the more targets you have to copy, the more first generic approvals you may expect to see in a given year if none of the regulatory barriers, like patents and exclusivity, stand in the way of approvals... Full

How Math Errors May Have Cost US FDA Millions In PDUFA Fees

(8/8, Derrick Gingery, Pink Sheet) ...Staffing changes and a lack of operational knowledge caused mistakes calculating the fiscal year 2023 and 2024 prescription drug user fees, which likely saved sponsors hundreds of thousands of dollars per submission and robbed the US Food and Drug Administration of needed funding...The FDA told the Pink Sheet that "the error occurred due to staff turnover in the organizations involved in the process and lack of process documentation." "The process is now sufficiently documented to ensure the error will not occur again," the agency added... Sub. Req'd

Drug Middlemen Legislation Faces Key Test in California Assembly

(8/9, Andrew Oxford, Bloomberg Law) ...California lawmakers are making a last-minute push before adjourning to restrain pharmacy benefit managers against the background of a national effort to rein in prescription drug prices. Proponents of the bill, led by pharmacists, argue SB 966 would help place needed safeguards on the middlemen who negotiate with drug manufacturers and manage prescription benefits for employers. They say those third parties have undermined competition and are financially squeezing smaller pharmacies... Sub. Req'd

In States With Health Care Spending Targets, Spending Growth Moderated In 2022 But Still Exceeded Targets

(8/8, Jessica Mar and January Angeles, Health Affairs) ...As of mid-2024, eight states have committed to a process to slow spending growth by establishing statewide targets for health care spending growth...In this article, we examine 2022 health care spending trends in these states and the factors that influenced these patterns. In short, we find that spending growth moderated in 2022, compared to 2021, but still exceeded targets in four out of the five states... Full

Health Canada Approves Two Formulations Of Celltrion's Stelara Biosimilar

(8/8, Adam Zamecnik, Generics Bulletin) ...Following past approvals for Alvotech and Amgen, Health Canada greenlighted Celltrion's Stelara biosimilar in most of the relevant indications, moving it ahead of Alvotech's product...Last month, the FDA approved Samsung Bioepis' and Sandoz's Stelara rival Pyzchiva. Alvotech and Teva secured a positive FDA nod for their Selarsdi version in April. However, Alvotech is collaborating with Teva on the biosimilar's development solely in the US. The company has deals with the likes of Fuji Pharma in Japan, Stada in Europe, and Jamp in Canada. The approval of Alvotech's Stelara biosimilar in Japan was described by the company as the first in global markets... Global Sub. Full

Greater Efforts Needed To Support European Decentralized Procedures

(8/8, David Wallace, Generics Bulletin) ...A better balance needs to be struck in allocating resources between Europe's centralized and decentralized procedures for generic approvals, Medicines for Europe has urged, pointing to current limitations on member states acting as reference member states for decentralized procedures... Global Sub. Full

UK Firms Given More Time To Submit Sales Data Under New Price Scheme

(8/8, Leela Barham, Pink Sheet) ...It appears that the complexity of dealing with older products under the VPAG is the main cause of delays at the health department in sharing reference prices with pharma companies. The Department of Health and Social Care has had to extend the deadline for pharmaceutical companies to submit product sales data because of delays in sharing reference prices with companies that have older branded medicines in their portfolios... Sub. Req'd

Novo Nordisk Found in Breach of UK Marketing Rules with 2022 CEO Interview On Wegovy

(8/8, Andrea Park, Fierce Pharma) ...This time around, the ABPI's Prescription Medicines Code of Practice Authority dove into a handful of media articles written about the Danish pharma's weight-loss drugs, ultimately concluding that one of the articles breached several clauses of the code. Among those, following an appeal, was the agency's most serious, Clause 2, designating that a drugmaker's actions are responsible for "bringing discredit upon, and reducing confidence in, the pharmaceutical industry."... Full

India Waives Local Clinical Trials Requirement to Fast-Track New Medicines

(8/9, The Pharma Letter) ...In a significant move aimed at expediting access to life-saving medications for Indian patients, the Indian government has waived the requirement for conducting local clinical trials for drugs that have already received approval from regulatory authorities in the USA, UK, Japan, Australia, Canada, or the European Union. Effective immediately, the decision will expedite the availability of new medications... Sub. Req'd

German Panel Endorses GSK, Pfizer RSV Vaccines for Elderly

(8/8, Ludwig Burger, Reuters) ...Germany's influential vaccine advisory panel said on Thursday that everyone in the country who is 75-years old or more should receive one of two new vaccines against the common respiratory infection RSV... Full

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