Monday, August 26, 2024

Zydus Life Shares Drop Over 6% Despite Sterling Deal, Drug Approval — Explained

(8/26, Meghna Sen, CNBC TV 18) ...Over the weekend, Teva received the USFDA approval for Asacol HD generic, used for ulcerative colitis. Jefferies said it believed the product accounted for 3-4% of Zydus' revenue and 8-10% of EBITDA in FY24...Citi said that with Teva's launch, sales of the product may fall by 40-50% from the current level, adding that impact of competition in this product should also reflect in the valuations... Full

Alvotech Beginning To Take Flight As Product Sales Treble In H1

(8/23, Dean Rudge, Generics Bulletin) ...Alvotech's non-license product sales nearly trebled to $65.9m in the first six months of the year, as the firm outlined expectations for its product revenues to overtake lower milestone revenues towards the end of 2024, amid solid gains for the Icelandic firm's interchangeable high-concentration 100mg/ml Simlandi (adalimumab-ryvk) in the US...[Alvotech's chief commercial officer, Anil Okay] "We expect this to evolve over time in a favorable manner and we anticipate further coverage as we move into 2025. We are very pleased with the progress of our partner Teva has made thus far."... Global Sub. Full

ARS Gets Early FDA Approval For Needle-Free Epinephrine

(8/23, Joseph Haas, Generics Bulletin) ...ARS Pharmaceuticals, Inc. got an ahead-of-schedule US Food and Drug Administration approval for its inhaled formulation of epinephrine for severe allergy attacks on August 9, and is now preparing to launch what one of its executives called "clearly a multibillion market opportunity" during a August 12, call with investors. Called neffy, the product is the first needle-free therapy for type 1 allergic reactions and will compete directly with EpiPen and other injectable epinephrine products, including a generic product from Teva Pharmaceutical Industries Ltd... Global Sub. Full

Celltrion Gets European Approval for Stelara Biosimilar

(8/26, Park Li-na, The Korea Herald) ...South Korean biopharmaceutical firm Celltrion announced Monday that it has received the European Commission's final approval for Steqeyma, a Stelara (ustekinumab) biosimilar used to treat various autoimmune conditions...Currently, Celltrion is progressing with other biosimilars, including CT-P47, an Actemra biosimilar; CT-P53, an Ocrevus biosimilar and CT-P55, a Cosentyx biosimilar... Full

Alembic Pharma Gets USFDA Nod for Betamethasone Valerate Foam

(8/24, Business Standard) ...Alembic Pharmaceuticals announced that it has received final approval from the US Food & Drug Administration for its Abbreviated New Drug Application Betamethasone Valerate Foam. The approved ANDA is therapeutically equivalent to the reference listed drug product, Luxiq Foam of Norvium Bioscience, LLC... Full

Belgium's UCB to Sell China Neurology, Allergy Business for $680 Mln

(8/26, Geert De Clercq, Yantoultra Ngui, Reuters) ...UCB a Belgian biopharmaceutical firm, said on Monday it would sell its Chinese neurology and allergy business to Singapore-based asset management group CBC and Abu Dhabi sovereign investor Mubadala for $680 million. The deal includes UCB's neurology portfolio comprising drugs like Keppra, Vimpat and Neupro, and anti-allergy medicines Zyrtec and Xyzal, commonly used to treat watery eyes and runny noses... Full

U.S. FDA Issues Observations to Dr . Reddy's Srikakulam Unit

(8/24, The Hindu) ...The United States Food and Drug Administration has issued a Form 483 with 3 observations to Dr. Reddy's Laboratories after inspecting its formulations manufacturing facility in Andhra Pradesh... Full

Strategies for Effective Biosimilar Education, Adoption

(8/25, Cameron Santoro, The Center For Biosimilars) ...Ivo Abraham, PhD, RN, director of the Center for Health Outcomes and PharmacoEconomic Research at the University of Arizona Cancer Center discussed educational tools that could help physicians overcome biosimilar adoption hesitancy, in an interview with The Center for Biosimilars®... Full

Embedding Into the Provider's Workflow is Key to a Specialty Drug's Success

(8/23, Adam J. Fein, Ph.D., Drug Channels) ...Moving away from a call center-centric approach to the use of e-services embedded into the provider's native workflow benefits providers, patients, and drug manufacturers alike. It minimizes administrative work and reduces friction, enabling providers right where they are. It gets patients on life-altering medications faster. And it removes barriers to provider adoption... Full

Access to Opioid Meds Varies by Pharmacy, Study Finds

(8/23, Meira Gebel, Axios) ...Patients seeking medication-assisted treatment for opioid use disorder may face significant barriers in accessing those life-saving drugs even after obtaining a prescription, according to a new study from Oregon State University and Johns Hopkins University...Researchers found pharmacies in more racially segregated and low-income areas across the U.S. were less likely to carry buprenorphine — one of few drugs considered to be the gold standard for treating opioid addiction — than pharmacies in more privileged counties... Full

Editorial: Don't Believe the Drug Cost Spin

(8/23, The Wall Street Journal) ...Democrats in Chicago this week boasted about saving seniors and taxpayers tens of billions of dollars on drug costs. Talk about deceptive advertising. The "savings" will be much less in practice, and price fixing could result in higher costs over time owing to less competition to Big Pharma from generic drugs. Here's what the politicians won't tell you... Sub. Req'd

Ozempic On Wall Street's List for 2027 Medicare Drug Negotiations

(8/23, Michael Erman, Reuters) ...Novo Nordisk, Pfizer, GSK drugs likely to be in 2027 Medicare negotiations...Other possible 2027 candidates include Pfizer's cancer drugs Ibrance and Xtandi, GSK's asthma and chronic obstructive pulmonary disease treatment Trelegy Ellipta, Teva's Huntington's disease treatment Austedo and Abbvie's irritable bowel syndrome drug Linzess, according to five analysts as well as researchers and company executives...Teva CEO Richard Francis said his company's forecasts for Austedo include a potential price cut under the Inflation Reduction Act and that the company is nonetheless projecting growth for the Huntington's disease treatment... Full

Ozempic Maker Defends High U.S. Price: It's ‘Helping' Reduce the Cost of Obesity

(8/25, Berkeley Lovelace Jr. and Meagan Fitzgerald, NBC News) ...The CEO of Novo Nordisk defended the high cost of Ozempic and Wegovy in the U.S., saying the blockbuster drugs are ultimately saving taxpayers money on obesity-related costs. "If you look at just the cost of obesity in the U.S., it's a disease that costs Americans more than $400 billion a year," Lars Fruergaard Jørgensen said in an interview on "NBC Nightly News." "And we are actually providing products that's actually helping take that cost burden off."... Full

Big Pharma Claims Lower Prices Will Mean Giving Up Miracle Medications. Ignore Them.

(8/24, Dylan Scott, Vox) ...It is a harrowing proposition: that in trying to control drug prices for 67 million Medicare patients now, we might inadvertently prevent the development of future drugs that could save lives. Implied, if not stated outright, is that we're putting a cure for cancer or Alzheimer's or some other intractable disease in jeopardy. But we have good reasons to believe that the current policy won't have such a trade-off any time soon... Full

For Pharma, Trump vs. Harris Is a Showdown Between Two Industry Foes

(8/26, Stephanie Armour, KFF Health News) ...The industry is increasingly under attack by lawmakers from both parties for drug prices most Americans regard as unreasonable, according to KFF polling, so the election outcome could be pivotal to drug companies' fortunes... Full

US Presidential Elections: Are Prescription Drug Pricing Reforms Losing Political Luster?

(8/23, Cathy Kelly, Pink Sheet) ...Democratic presidential nominee Kamala Harris did not refer to drug pricing reform in her speech at the party convention last night, nor did Republican nominee Donald Trump at his convention last month...Although the Democratic platform includes several policies aimed at expanding the Medicare drug pricing provisions in the IRA to the commercial market, they seem like a long shot... Sub. Req'd

J&J Takes Aim at Hospital Drug-Discount Program

(8/23, Melanie Evans and Peter Loftus, The Wall Street Journal) ...Johnson & Johnson told certain hospitals around the U.S. Friday, in a letter reviewed by The Wall Street Journal, they will have to pay full price for two drugs that the company has sold at a discount under the drug-savings program and can apply later for a rebate. The switch, which would take effect Oct. 15, would be a sharp change from the past pharmaceutical industry practice of providing the discount upfront. Hospital industry officials said the shift could strap them financially, because it would force them to hand over significant sums and then wait months to get the money back... Sub. Req'd

U.S. Agency Slaps Down a J&J Plan to Switch Payments for 340B Hospitals

(8/23, Ed Silverman, STAT Plus) ...A U.S. government agency said that a planned move by Johnson & Johnson to alter payment methods for some hospitals participating in a controversial drug discount program was "inconsistent" with federal law and requires approval before the company can proceed... Sub. Req'd

CDER Chief Says 'Standards Have Not Changed,' Explaining Increase in CRLs for Biologics

(8/23, Zachary Brennan, Endpoints News) ...The FDA initially rejected nearly half of all biologics applications received last year, many for quality-related CMC issues that need to be improved upon, according to CDER Director Patrizia Cavazzoni. "Our standards have not changed," she said Monday at a Duke University and FDA event at the National Press Club in Washington, DC. "We have exactly the same standards as we had in 2018 and 2019." What CDER is seeing is quality-related issues, Cavazzoni said — "and we really need to work on this."... Full

CMS Finalizes CED Guidance Despite Criticism From Industry, Lawmakers

(8/23, Maaisha Osman, Jessica Karins, InsideHealthPolicy) ...The pharmaceutical industry has argued that CED determinations unfairly restrict patient access and stifle innovation, but CMS says that coverage through CED can actually speed up beneficiary access to cutting-edge technologies while improving the chances of patient outcomes. CMS has applied CEDs to products approved through FDA's accelerated approval pathway where, like FDA, it wants to see more evidence that the products work as intended, but critics say the CMS is second guessing FDA's authority... Sub. Req'd

New and Revised PSGs – Time to Check Your Portfolio!

(8/23, Bob Pollock, Lachman Consultants) ...Yesterday, the FDA announced the issuance of 14 new product-specific guidances (PSGs) and 54 revised guidances that provide the FDA's current thinking on the requirements for bioequivalence testing for generic drugs...This may pose problems for firms that already have any of these products in development, currently undergoing biostudies or with biostudies completed, or have applications about to be filed or already filed for any of the products on these lists... Full

The Fight for Drug Pricing Transparency

(8/25, Los Angeles Times) ...California Attorney General Rob Bonta recently led 21 attorneys general in filing an amicus brief in Pharmaceutical Res. & Manufacturers of Am. v. Stolfi in support of laws that increase drug price transparency...The amicus brief also highlights the various measures that a bipartisan group of states have adopted to hold pharmaceutical manufacturers accountable, including laws promoting drug price transparency... Full

As Medicare Negotiates Lower Prices, We Are Slashing Drug Costs for New Jersey Residents

(8/22, Frank Pallone Jr., Northjersey.com) ...The work doesn't stop here. My bill, the Lowering Drug Costs for American Families Act, aims to bring these same benefits to those with private insurance. It would expand drug price negotiations to include all Americans with private health insurance and increase the number of drugs subject to negotiation each year from 20 to 50, broadening the program's reach and delivering even more savings... Full

Big Pharma Has Big Asks When it Comes to Investing in the UK

(8/23, Financial Times) ...The Treasury described its discussions with AstraZeneca over the investment as positive, coming up with warm words about making the UK a world-leading hub for innovative medicines. Given that Labour's manifesto put stability at the core of its life sciences policy, it risks being painted as an unreliable partner if it plays hardball. Yet even if this issue is resolved, there will be other clashes between the pharma sector and a cash-strapped government... Sub. Req'd

Targeted Incentives Prove Effective in Boosting Adalimumab Biosimilar Uptake in France

(8/24, Deana Ferreri, PhD, The Center For Biosimilars) ...A study comparing 2 different financial incentive programs in France to encourage adalimumab biosimilar use concluded that incentivizing individual clinical units was more effective than incentivizing entire hospitals... Full

Pharma Companies Seek More Time to Implement Revised Norms On Manufacturing Practices

(8/26, The Economic Times) ...India's pharmaceutical industry has sought at least two more years to implement the revised pharma manufacturing rules under Schedule M, saying it is necessary to ensure survival of micro, small and medium enterprises...Pharma lobby groups have written to the health minister, seeking an extension of the December 2024 deadline to December 2026, citing lack of resources and challenges faced by the industry in implementing the revised norms... Full

Govt Bans 156 Fixed-Dose Combination Drugs Administered As Painkillers, Antibiotics

(8/26, ANI) ...The Central Government has prohibited as many as 156 combination drugs that are often administered as painkillers, multivitamins and antibiotics, for fever and cold, among others...When asked about the impact on pharmaceutical companies, Mr. Jain said, "They have been given the opportunity to provide data supporting their products. Those with adequate supporting data will continue, while companies lacking such data will have to withdraw their products."... Full

CDSCO Declares 70 Drugs Tested in July as NSQs

(8/24, Pharmabiz.com) ...The Central Drugs Standard Control Organisation has released a list of 70 drug samples declared as Not of Standard Quality, with samples of drugs labelled as manufactured by some of the major companies failing the quality test...The list of drugs failed the quality test by the CDSCO and Central Laboratories during the month of July include samples of budesonide nebuliser suspension BP (Budecort Respules) and tamsulosin and dutasteride tablets (Urimax-D) labelled as manufactured by Cipla Ltd, amoxycillin and potassium clavulanate tablets IP (Pressclav625) labelled as manufactured by Aurobindo Pharma, and carboplatin USP labelled as manufactured by Hetero Labs... Full

A.P. Pharma Unit Blast: Officials Find Key Design Faults in Plant

(8/24, Sumit Bhattacharjee, The Hindu) ...The Director General, State Disaster Response and Fire Services Department, Madireddy Pratap, told The Hindu on Saturday, August 24, that the reactor, the key machine and the most volatile component, was placed on the second and third floor of the three-storey building (including ground floor). And directly under the reactor, an electric switch panel (MCC) was located on the ground floor. "It is like, lighting a fire under a fuel tank, as reactors contain and process highly-volatile and combustible solvents and chemicals," he said... Sub. Req'd

Egypt's PM, UPA Review Progress On Pharmaceutical Projects, Raw Materials Localisation

(8/26, ZAWYA) ...Egypt's Prime Minister Mostafa Madbouly met with Bahaa El-Din Zidan, Head of the Egyptian Unified Procurement Authority (UPA), on Sunday to review progress on a number of pharmaceutical projects aimed at bolstering local production and reducing reliance on imports. The meeting focused on the expansion of 24 ambulance pharmacies across various governorates, with a review of the timetable for their opening in the coming months. The meeting also reviewed the progress of the strategic warehouses project for medical products and devices... Full

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