Tuesday, January 9, 2024

Senate Health Committee Investigates Inhaler Manufacturers for High Prices

(1/8, Lia DeGroot, Endpoints News) ...Senate Democrats on the health committee are pressing inhaler manufacturers over their high US prices and how they've used the patent system to maintain exclusivity, according to letters sent to AstraZeneca, Boehringer Ingelheim, GSK and Teva on Monday... Full

Sanders, Democrats Launch Investigation Into Asthma Inhaler Pricing

(1/8, Nathaniel Weixel, The Hill) ...Sanders, chairman of Senate's Health, Education, Labor and Pensions Committee, sent letters to the CEOs of the four biggest manufacturers of inhalers sold in the United States – AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline and Teva — demanding information and documents on internal strategic communications, patient assistance programs and the costs involved in the manufacturing of inhalers... Full

Sanders Targets High Price of Inhalers

(1/8, Dan Diamond and McKenzie Beard, The Washington Post) ..."Our goal, obviously, is to put pressure on these companies to substantially lower the price of inhalers in America," Sanders said in an interview on Friday...The Vermont senator called it "totally absurd" that Teva charges $286 for an inhaler in the United States that's sold for $9 in Germany, or that AstraZeneca charges $645 here for an inhaler sold for $49 in Britain... Sub. Req'd

Sanders, Other Lawmakers Open Probe into Asthma Inhaler Makers Over Pricing, Patent Maneuvers

(1/8, Ed Silverman, STAT Plus) ...The lawmakers maintained that the companies — AstraZeneca, GSK, Teva Pharmaceutical, and Boehringer Ingelheim — charge between $200 and $600 in the U.S. for their inhalers, which are typically purchased monthly, but sell them for a fraction of those prices elsewhere, even though the inhalers have been available for decades with few significant changes made... Sub. Req'd

Bernie Sanders, Senate Democrats Open Investigation into Price of Asthma Inhalers

(1/8, Meg Tirrell, CNN) ...Independent Sen. Bernie Sanders, who chairs the committee, as well as Democratic Sens. Tammy Baldwin, Ben Ray Lujan and Edward Markey, sent letters to the chief executives of AstraZeneca, Boehringer Ingelheim, GSK and Teva about their pricing and other business practices. They requested the information by January 22... Full

GSK, Teva, AstraZeneca Under Senate Probe Over Asthma Inhaler Pricing

(1/8, Dulan Lokuwithana, Seeking Alpha) ...HELP committee members led by Sen. Bernie Sanders (I-Vt.) sent letters to the CEOs of GSK, Teva, AstraZeneca, and German drugmaker Boehringer Ingelheim, demanding information on pricing and other business practices related to asthma inhalers by Jan. 22...The investigation comes after the U.S. Federal Trade Commission warned drugmakers, including GSK and Teva, for violating patent listing procedures for products such as asthma inhalers... Full

As Bernie Focuses On Older Drug-Device Combos, Can Innovators Catch Their Breath?

(1/8, Sarah Karlin-Smith, Pink Sheet) ...It's not great news for the named players – AstraZeneca PLC, Boehringer Ingelheim GmbH, GSK plc, and Teva Pharmaceutical Industries Ltd. – but there's perhaps a silver lining for the entire branded industry in the focus of the Senate HELP Committee's latest pharma investigation. The investigation centers on decades-old drugs that have largely managed to skirt competition and keep prices high, rather than newer industry innovations. This is an old story for industry when it comes to political scrutiny and as such it doesn't represent bolder threats from Sanders, perhaps the most hostile US Congressman to pharma... Sub. Req'd

Teva Once Again Most Valuable Company On TASE

(1/8, Netanel Ariel and Shiri Habib-Valdhorn, Globes) ...After just over a year in the job, Teva Pharmaceutical Industries Ltd. CEO Richard Francis can afford a smile. For the first time in three and a half years the Israeli pharmaceuticals company is the most valuable company on the Tel Aviv Stock Exchange...Regardless of whether Teva's share remains top, it has performed impressively over the past six months rising 50% and over all of 2023 the share price rose 14.5%... Full

Amiti Ventures Joins Pharma Venture Studio AION Labs As S Strategic Partner

(1/8, James Spiro, CTECH) ...AION Labs, a venture studio focusing on the adoption of AI and computational science to solve therapeutic challenges, has announced a new strategic partnership with Israeli early-stage VC firm Amiti Ventures...The partnership between the two parties will help advance healthcare towards more patient-centric precision medicine and help bring new treatments to market. The venture includes companies like AstraZeneca, Merck, Pfizer, Teva, the Israel Biotech Fund, and Amazon Web Services, and is powered by BioMed X with the support of the Israeli Government via the Israel Innovation Authority... Full

Bayer Pharma Head Sees Brighter Future With Deals, New Drugs

(1/9, Naomi Kresge, Cynthia Koons and Tim Loh, Bloomberg) ...Bayer AG is considering doing deals in the range of €1 billion to €5 billion ($1.1 billion to $5.5 billion) as the drugmaker seeks to rebuild its pipeline of new medicines. Top drugs are losing exclusivity and a promising experimental candidate recently failed. But Bayer's pharma head, Stefan Oelrich, said Monday that the company has built up a portfolio of earlier-stage assets that show a lot of promise, and he's also open to licensing deals for existing drugs... Sub. Req'd

Adalimumab Uptake Set For A Boost As CVS Drops Humira From Formularies

(1/9, David Wallace, Generics Bulletin) ...At the same time as it disclosed the removal of Humira from its formularies, CVS also announced that originator AbbVie had agreed to supply CVS Health subsidiary Cordavis...Speaking at the J.P. Morgan Healthcare Conference in San Francisco this week, CVS Health president and CEO Karen Lynch said that the thinking behind Cordavis was to "bring a sustainable biosimilar market to the US." "We initiated the Cordavis company to really bring a viable biosimilar marketplace," she explained, because the biosimilars market "hasn't taken off as we expected."... Global Sub. Full

AbbVie Launches PRODUODOPA® (Foslevodopa/Foscarbidopa) for People Living with Advanced Parkinson's Disease in the European Union

(1/9, AbbVie) ...AbbVie today announced the launch of PRODUODOPA® (foslevodopa/foscarbidopa) in the European Union for the treatment of advanced Parkinson's disease with severe motor fluctuations and hyperkinesia (excessive movement) or dyskinesia (involuntary movement), and when available combinations of Parkinson's medicinal products have not given satisfactory results... Full

Adalvo Celebrates Unique European Nod For Prolonged-Release Pregabalin

(1/8, David Wallace, Generics Bulletin) ...Adalvo, the B2B unit of the Alvo group of companies, has announced a successful decentralized European approval for its pregabalin prolonged-release tablets, with a launch imminent. The "milestone" for its value added medicines program could allow the firm to offer what it has previously billed as "the first once-daily pregabalin formulation." Adalvo, the B2B unit of the Alvo group that also includes sister companies Alvogen and Alvotech, has announced a European approval through the decentralized procedure for its pregabalin prolonged-release tablets... Global Sub. Full

GSK, Moving Fast to Buy Aiolos, Pays $1B to Challenge Amgen, AstraZeneca for Asthma Market

(1/9, Nick Paul Taylor, Fierce Biotech) ...Seventy seven days after Aiolos Bio launched to the public, GSK has disclosed a deal to buy the biotech and its phase 2 asthma treatment for $1 billion upfront and up to $400 million in regulatory milestones...GSK has weighed up the competition and bet up to $1.4 billion on AIO-001. In a statement, Tony Wood, chief scientific officer at GSK, called AIO-001 a potentially best-in-class medicine that could expand the company's biologics portfolio to the 40% of severe asthma patients with low T2 inflammation... Full

Regeneron Reports Preliminary Q4 U.S. Sales of Eylea at $1.46 Bln

(1/8, Leroy Leo, Reuters) ...Regeneron Pharmaceuticals said on Monday its franchise of eye drug Eylea recorded preliminary sales of $1.46 billion in the United States in the fourth quarter. Wells Fargo analyst Mohit Bansal last week pegged consensus Wall Street estimates for U.S. sales of Eylea at $1.53 billion... Full

Bristol Myers Expects to Launch 16 New Products Through 2030 - CEO

(1/8, Sriparna Roy and Sneha S K, Reuters) ...Bristol Myers Squibb CEO Christopher Boerner said on Monday the drugmaker expects to add 16 new products to its portfolio by the end of the decade. The drugmaker said it would focus on licensing, partnerships and bolt-on purchases as opposed to large acquisitions after signing two multi-billion dollar deals last month... Full

Drugmakers Kick Off Industry Conference With Two Cancer Deals

(1/8, Bhanvi Satija and Sriparna Roy, Reuters) ...Johnson & Johnson and Merck on Monday announced plans to buy cancer therapy developers on the first day of a major U.S. healthcare conference, igniting what industry participants hope will be a strong year for deals after a solid end to 2023. Deals announced on Monday had a combined equity value of more than $6 billion, including one by medical device maker Boston Scientific for Axonics Inc... Full

Pfizer CEO Says it's Back to Basics After Painful 2023 for Investors: #JPM24

(1/8, Drew Armstrong, Endpoints News) ...In a wide-ranging lunch with reporters ahead of the company's presentation at the JP Morgan Healthcare Conference on Monday, Bourla talked about Pfizer's challenging past year and the changes it's made. That has included broad cuts meant to strip excess costs from its Covid period, executive changes, and focusing on deleveraging and returning capital. "I recognize that the last year was a very bad year for investors," Bourla said of 2023, in which the drugmaker's stock $PFE dropped 44%. "I think it will be a very good year in 2024."... Full

What Was the Most-Repeated Word in CVS Health CEO's JPM Presentation?

(1/8, Arundhati Parmar, MedCity News) ...In a space of five minutes in the roughly 12:30-minute presentation on CVS Health at the 42nd annual J.P. Morgan Healthcare conference in San Francisco on Monday, Karen Lynch said a version of the word "transparency" six times...CVS Health's moves at greater price transparency is occurring within this context of federal and Congressional efforts to rein in the industry. Lynch added that CVS Health is also attempting to have price transparency in how it reimburses pharmacies. She spoke about this at some length... Full

How Mark Cuban and Amazon's Online Pharmacies Unlock Growth Opportunities for All

(1/8, Mark Hamstra, CO) ...Direct-to-consumer pharmacy platforms lean into consumers' heightened demand for value-driven digital convenience and personalized service, unlocking growth opportunities for startups like Mark Cuban's Cost Plus Drugs to big players like Amazon and Kroger alike. The DTC trend is poised to shape the next era of growth in the retail pharmacy landscape, "as behavior changes sparked by COVID-19 continue beyond the pandemic," according to McKinsey... Full

The Big Three PBMs' 2024 Formulary Exclusions: Biosimilar Humira Battles, CVS Health's Weird Strategy, and the Insulin Shakeup

(1/9, Adam J. Fein, Ph.D., Drug Channels) ...For 2024, the three largest pharmacy benefit managers (PBMs)—Caremark (CVS Health), Express Scripts (Cigna), and OptumRx (United Health Group)—have again each excluded 600 or more drugs from their standard formularies...This year, Humira and its 13 biosimilars will provide the most intriguing formulary drama...CVS Health will lean into the craziness with a widely misunderstood—but unambiguously anti-biosimilar—Humira strategy. There are also unusual formulary developments for insulin products, many of which experienced massive list price cuts for 2024. Read on for my deep dive into these two therapeutic categories... Full

Aurobindo Pharma Gains On USFDA Relief for Telangana Unit

(1/9, Money Control) ...Aurobindo Pharma share price gained in the opening trade on January 9 after the company received establishment inspection report from the US Food and Drug Administration. The USFDA had inspected the pharma firm's formulation manufacturing facility in Chitkul in Telangana in September. The establishment inspection report has classified the facility as "Voluntary Action Indicated"... Full

Walgreens to Pay $360 Million to Humana in Drug Pricing Settlement

(1/8, Mike Scarcella, Reuters) ...Walgreens has agreed to pay $360 million to healthcare insurer Humana to settle a lawsuit claiming that the retail pharmacy giant for years overcharged for prescription drug reimbursements...Walgreens also said it would resolve a related lawsuit in District of Columbia Superior Court against U.S. law firm Crowell & Moring, which represented Louisville-based Humana in the arbitration... Full

Respiratory Illnesses Elevated in 38 States, According to CDC

(1/8, Youri Benadjaoud, ABC News) ...Some 38 states plus New York City are experiencing "high or very high" levels of respiratory illness activity, according to the CDC. Of those states, 21 are experiencing "very high" activity. Last week, 31 states were experiencing "high or very high" activity..."A steady increase in respiratory illnesses is a common annual trend, typically fueled by holiday gatherings and travel," says ABC News contributor John Brownstein, Ph.D. "This year is no exception. With January and February often marking the peak of such illnesses, it's crucial to exercise heightened vigilance now."... Full

The ‘Tripledemic' We Hoped to Avoid

(1/8, Nathaniel Weixel and Joseph Choi , The Hill) ...The U.S. headed into the current respiratory viral season with three preventive drugs against RSV for the first time and updated COVID-19 vaccines. But uptake of these drugs has been lackluster due to waning enthusiasm or difficulty in accessing them...Just less than a third of adults say they've gotten the updated COVID-19 vaccine according to polling from Gallup, with 51 percent saying they don't plan to get the latest dose at all. "The numbers are not looking good," Marcus Plescia, chief medical officer for the Association of State and Territorial Health Officials, told The Hill... Full

Santa Clara County Providing Free Narcan by Mail to Residents

(1/8, Grace Hase, The Mercury News) ...With fentanyl and other opioids continuing to take a deadly toll on the country, Santa Clara County has begun distributing Narcan, the opioid overdose-reversing nasal spray, by mail to residents free of charge...Santa Clara County has already stocked free Narcan in several of its libraries, making the mail-order effort just the latest initiative to combat the opioid crisis...Supervisor Cindy Chavez said adding a mail order program was the logical next step as many residents are already used to getting their prescriptions or COVID-19 tests in the mail. In her conversations with residents, she's learned that not everyone feels comfortable picking up Narcan at their local library out of fear that others might think they're a drug user themselves... Full

White House's Drug Patent Plan Undercuts Research and Innovation

(1/9, Paul Michel and Kathleen O'Malley, Bloomberg Law) ...Retired federal appeals court judges Paul Michel and Kathleen O'Malley argue that the Biden administration's planned use of march-in rights to control drug prices has legal and policy shortcomings...The Bayh-Dole Act catalyzed decades of US innovation by decentralizing the licensing process for the results of federally funded research. Upending the law over opposition to some drug prices is short-sighted—and threatens to choke off investment into tomorrow's life-changing and lifesaving technologies... Full

Sen. Maggie Hassan On What Congress Must Do Next To Fight The Opioid Crisis

(1/9, Maggie Hassan, STAT) ...The SUPPORT Act, which established vital infrastructure for communities in New Hampshire and across the country to treat addiction, help people recover, and prevent substance misuse in the first place...But the evidence, including from the National Institutes of Health, shows that medication-assisted treatment works better than any other treatment, because it helps cut the craving to use opioids like fentanyl. This evidence led the drafters of the original SUPPORT Act to require that every state provide Medicaid coverage for medication-assisted treatment. But now that the SUPPORT Act has expired, this requirement ends in 2025, jeopardizing access to medication-assisted treatment, as many states could choose not to cover it under Medicaid anymore... Full

US FDA Says Opioid Database Firm With Purdue Pharma Connections Reported No Conflicts

(1/8, Derrick Gingery, Pink Sheet) ...Amid criticism of its contract to evaluate opioid data from the Researched Abuse, Diversion and Addiction-Related Surveillance survey programs, the FDA says federal databases lack the necessary information on opioid misuse. A database on opioid misuse and abuse slated for an FDA contract did not report any potential conflicts of interest and is attractive because it includes information federal agencies do not have, the US Food and Drug Administration said following criticism that the arrangement was inappropriate because the database was initially developed by the maker of OxyContin... Sub. Req'd

New Year's Predictions From FDA Leadership Past And Present: GLP-1s, Mental Health, Big Data

(1/8, Brenda Sandburg, Pink Sheet) ...US Food and Drug Administration Commissioner Robert Califf and three of his predecessors shared what they think will be positive developments in the new year, including continued health improvements from GLP-1 obesity treatments and a resurgence in drugs targeting mental health disorders. Califf, former acting commissioner Janet Woodcock, and former commissioners Scott Gottlieb and Mark McClellan spoke on a panel at the Center of Excellence in Regulatory Science and Innovation summit on January 7, in San Francisco... Sub. Req'd

Canada Says Bulk Importation Not An Effective Solution to High Drug Prices in US

(1/8, Kanishka Singh, Reuters) ...The Canadian government thinks bulk importation will not provide an effective solution to the problem of high drug prices in the United States after the U.S. Food and Drug Administration allowed Florida to import cheaper drugs from Canada, Health Canada said on Monday...In the past, Canada's government has opposed any U.S. plans to buy prescription medicines, citing threats to the country's drugs supply or higher costs for its own citizens... Full

PhRMA Readies Suit Over Florida's Newly Authorized Canadian Drug Import Plan

(1/8, Zachary Brennan, Endpoints News) ...Industry group PhRMA plans to again sue over a program that the FDA authorized late last week to allow Florida to begin bulk prescription drug imports from Canada, according to a person familiar with the matter..."I do think that there has been a little bit of false hope in what this type of policy could yield as far as savings to the consumer and the payer," Antonio Ciaccia, CEO of the nonprofit drug pricing data tracker 46brooklyn Research, previously told Endpoints News... Full

States Eye Drug Imports From Canada After Florida Wins Approval

(1/9, Celine Castronuovo, Bloomberg Law) ...The Food and Drug Administration on Jan. 5 gave the Sunshine State the green light to move forward with its plans—the first time the federal agency has authorized a state to import prescription drugs in bulk from another country. Eight other states—including Colorado, Texas, and Vermont—have enacted laws to establish their own processes for foreign drug imports, but have yet to get federal sign off. Officials from Colorado and Texas said they were encouraged by the news, as Colorado awaits a decision from the FDA on its own program. Texas is the most recent state to enact a foreign drug import law, and plans to submit its own application to the FDA "in the near future," the Texas Health and Human Services Commission said in an email... Full

Florida's Gambit to Import Drugs from Canada: ‘A Complicated Road' Ahead

(1/8, Ed Silverman, STAT Plus) ...Last week, the Food and Drug Administration granted Florida permission to import medicines from Canada, a controversial idea that supporters say is a necessary move toward lowering the cost of prescription drugs in the U.S...Other states are likely to follow suit. Yet there is no assurance the gambit will work, given the means the pharmaceutical industry has to obstruct it. To sort out the issues and unknowns, STAT spoke with Jane Horvath, a former health care policy strategist at Merck and a consultant who has previously worked with the National Academy for State Health Policy, a nonprofit that helps state officials and lawmakers develop programs to lower drug costs... Sub. Req'd

Is International Prescription Drug Pricing The Next Step For Florida?

(1/8, Christine Jordan Sexton, Florida Politics) ...House Health and Human Services Committee Chairman Randy Fine filed legislation (HB 1431) to establish "international reference pricing" for drugs, essentially limiting prescription drug prices in Florida to those paid by other countries, including those with socialized health care. On Monday, Fine held a two-hour meeting and scheduled presentations by policy experts to lay the groundwork he hopes will translate to support for the bill... Full

IGBA Announces Leadership Change

(1/8, IGBA) ...The International Generic and Biosimilar Medicines Association, representing global manufacturers of generic and biosimilar medicines, announced today that Suzette Kox, the first IGBA Secretary General, has passed on the baton to Dr. Susana Almeida. With over 20 years of substantial contribution to the role of the European and international generic and biosimilar medicines industry's trade bodies, Susana also brings significant experience in the process of international harmonisation of standards through the International Conference on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use... Full

IGBA Appoints New Secretary General As Kox Steps Down

(1/8, David Wallace, Generics Bulletin) ...Inaugural IGBA secretary general Suzette Kox has stepped down from the role after five years, passing leadership of the organization to Susana Almeida. At the same time, Medicines for Europe director general Adrian van den Hoven has taken up the position of IGBA chair for 2024...David Gaugh, interim CEO of the US Association for Accessible Medicines – who has served as the IGBA's chair for most of 2023 – said the global industry organization "thanks Suzette for her leadership during these past five years, which established IGBA as an indispensable actor in global health conversations."... Global Sub. Full

Companies Told To Prepare For New Rules On UK-Wide Drug Approvals

(1/8, Ian Schofield, Pink Sheet) ...The European Medicines Agency has published guidance on some of the changes that pharmaceutical companies will need to make before new legislation is implemented next year allowing the UK regulator, the MHRA, to grant UK-wide approvals to products that fall within the scope of the EU centralized procedure. At present, EU centralized approvals are valid in Northern Ireland, with MHRA approvals of such products being valid only in Great Britain... Sub. Req'd

EMA To Become Observer Of FDA's Project Orbis Early This Year

(1/8, Eliza Slawther, Pink Sheet) ...The European medicines regulator has put in place the necessary arrangements to begin watching the Project Orbis process imminently but has maintained its stance that the initiative focuses only on the "magic moment" of a drug approval...A spokesperson for the EMA told the Pink Sheet that the "administrative elements" that will allow the agency to observe the Project Orbis initiative "are now in place," which mainly consisted of establishing confidentiality arrangements with all the participating Orbis partner authorities. "We will start following Project Orbis discussions in early 2024," the agency added... Sub. Req'd

India Poised To Be An Emerging Hub For Biologics & Biosimilars: Jt Sec, DoP

(1/9, Shardul Nautiyal, Pharmabiz.com) ...India is poised to be an emerging hub for biologics and biosimilars with an estimated CAGR of 22% in the near future. It, today, has 200 plus biosimilars in pipeline and 98 biosimilars approved in FY19 in the US and EU. It is also strongly foraying into innovator drugs and complex generics in the coming decade with enhanced focus on technology platforms like mRNA, Cell and Gene therapy, said Ravindra Pratap Singh, joint secretary, Department of Pharmaceuticals... Full

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