As Congress weighs drug price restraints, ICER calls out
The group uses a methodology the federal government could follow in its hunt to restrain costs, looking for drugs with significant healthcare spending and large increases. ICER started with 250 of the top-selling drugs in the U.S. in 2020, and excluded 228 that had list-price increases 2% or less above the medical consumer price index.
Actived: 1 days ago
Democrats' drug pricing plan, while scaled back, could
(8 days ago) Small molecule drugs are typically given as pills, while biologics are infused or injected. President Joe Biden has endorsed the plan, as have key Democratic lawmakers, and legislative language emerged late Wednesday. While it's not clear which specific drugs could be affected, drug spending data from CMS provides some clues.
The top drugs that could be impacted by an obscure
(4 days ago) Some newer drugs with quickly growing sales could enter this top 10 by 2024, based on sales projections. Sanofi and Regeneron's eczema and asthma drug Dupixent, AbbVie and Johnson & Johnson's lymphoma treatment Imbruvica and AstraZeneca's cancer therapy Tagrisso — all expected to be in the top 10 highest selling drugs by 2026, according to
Otsuka partners with Sunovion, Sumitomo in neurology drug
(Just Now) The drugs are already under development at Sumitomo's subsidiary Sunovion Pharmaceuticals, a biopharma based in Marlborough, Massachusetts. Two are in Phase 3 testing for schizophrenia and bipolar depression; the other two are in Phase 1 development, and the indications for them are still to be determined.
Pfizer stocks cancer drug pipeline with $2.3B deal for
(7 days ago) Since 2015, seven Pfizer drugs have been approved to treat breast and lung tumors as well as leukemia — including the company's top-selling cancer medicine, Ibrance. Pfizer has also supplemented its own research and development efforts with high-priced acquisitions, paying billions of dollars in deals for Medivation and, more recently, Array
Vertex moves pain drug into mid-stage testing BioPharma Dive
(7 days ago) Vertex has been developing small molecule drugs that inhibit this channel as a way to create a new kind of pain treatment that doesn't have the addictive potential of opioids. So far, the company has looked at the impact of these drugs on several pain types, including acute, neuropathic and musculoskeletal.
Bristol Myers' top autoimmune drug prospect takes a hit in
(6 days ago) The drug is seen as a potential top-seller, leading a new class of oral drugs that could challenge the injectable biologics used by millions of patients with different autoimmune diseases. Deucravacitinib could also soften the blow of losing Otezla, an anti-inflammatory medicine Bristol Myers was forced to sell as part of its acquisition of
Big pharma backed away from brain drugs. Is a return in
(9 days ago) Drugs for those conditions come with regulatory incentives and can be sold at high price tags, potentially making an investment more attractive. “These days, it does seem like pharma is increasingly interested in the orphan business model,” Phil Nadeau of …
GSK returns to brain drugs with major biotech deal
(7 days ago) Brain drugs used to be of high interest to most major pharmaceutical companies. In the 1990s, GSK, Pfizer and Eli Lilly were at the forefront developing a new, lucrative class of antidepressants. And by the early 2000s, AstraZeneca and Bristol Myers Squibb had built multibillion-dollar businesses around antipsychotic medications.
Amylyx, faced with longer FDA path for promising ALS drug
(5 days ago) Few drugs are available for ALS, a devastating disease that damages nerve cells in the brain and spinal cord. In the U.S., treatment is largely limited to Radicava, a newer, modestly effective drug from Japan's Mitsubishi Tanabe Pharma, and riluzole, an older and now generic medicine.
Bayer opens OTC drug manufacturing plant in China
(2 days ago) Bayer last week announced the opening of its second-largest OTC drug manufacturing facility in the Asia-Pacific region. Located in Yunnan, China, the plant will produce OTC meds along with traditional Chinese medicines (TCM). The site was acquired by Bayer when it bought the Chinese pharmaceutical company Dihon in 2014.
A worrisome safety signal slows Merck's HIV ambitions
(8 days ago) Dive Brief: Merck & Co. has decided to halt development of one of its experimental HIV drugs while keeping a closer eye on another, after safety concerns arose in a clinical trial testing a combination of the two medicines. According to Merck, a mid-stage study found that patients taking its drugs, known as MRK-8507 and islatravir, had
US stocks up on COVID-19 antibody drugs amid shortage
(8 days ago) The U.S. government will buy nearly 1.8 million additional doses of COVID-19 antibody treatments from makers Regeneron and Eli Lilly, stocking up on the drugs as usage soars in states hit hard by a wave of coronavirus infections driven by the more infectious delta variant. The bulk of the order will be supplied from Regeneron, which agreed to
Neurocrine stocks up on a biotech's psychiatric drugs
(8 days ago) These drugs have yet to reach human testing, but the most advanced of them — a potential treatment for schizophrenia — is expected to enter a mid-stage clinical trial in 2022. The companies have agreed to jointly research and develop Sosei's drugs through Phase 1 clinical studies, with Neurocrine funding the work.
Sage antidepressant succeeds in key study, but data raise
(Just Now) Sage has also hoped testing would show zuranolone to be safer than existing drugs for depression, some of which come with warnings about the risk of suicidal thoughts and behaviors. But Sage has had trouble proving the drug's worth. A Phase 3 study failed in late 2019, forcing the company to change up its plans for clinical development. Such
The orphan drug dilemma: How to price for a tiny market
(Just Now) Large pharmas began collecting orphan indications for drugs that were anything but in order to benefit from the incentives under the Orphan Drug Act. In fact, several of the world’s top-selling drugs, including AbbVie Inc.’s Humira (adalimumab) and Amgen Inc.'s Enbrel (etanercept), have an orphan indication, giving these drugmakers
Denali drug for rare brain disease disappoints investors
(9 days ago) Large-molecule drugs like DNL310 can have a particularly hard time getting past. For Denali, whose research focuses on neurodegenerative diseases, finding a way into the brain is crucial. The company has been trying to address this challenge with a technology that uses engineered antibodies to encourage cells in the barrier to transport drugs
Amgen cuts Cytokinetics loose after heart drug
(Just Now) Dive Brief: Amgen on Monday said it will hand back rights to two cardiovascular drugs to their owner, Cytokinetics, including a heart failure medicine that delivered disappointing late-stage data six weeks ago. Cytokinetics will discuss a regulatory submission with the Food and Drug Administration based on the finding that the drug prevented heart failure complications.
With safety a concern, Merck, Gilead pause study of HIV drugs
(8 days ago) Due to safety concerns, Gilead and Merck & Co. have temporarily stopped enrolling patients in a key clinical trial testing two of their experimental drugs as a combination treatment for HIV. The decision, announced Wednesday, comes less than a week after Merck revealed that dosing had been stopped in a separate study evaluating its drug
Atea, Roche change plans for oral COVID-19 drug after
(6 days ago) Atea and Roche now plan to change the design of their ongoing Phase 3 trial. Doing so will delay the expected results until late 2022, however, by which time multiple other oral COVID-19 drugs, led by Merck & Co.’s molnupiravir, could reach the market. Shares of Atea, one of 2020’s top biotech IPOs, plummeted by more than 60% in early
Little-known drug manufacturer gets big contract for COVID
(4 days ago) The contract starts with a four-year award of $354 million, which can be extended to a 10-year award worth $812 million total. Phlow said BARDA's money has already allowed it to manufacture 1.6 million doses of five essential generic medicines used to treat COVID-19 patients. The medicines, which include a sedative, a pain management drug, and
Merck matches Roche in search for next cancer
(Just Now) Merck and Roche, the latter of which sells the Keytruda rival Tecentriq, are now both betting on drugs that block TIGIT, an immune cell protein that tumors seem to be able to co-opt to blunt the body's response to cancerous growths. In May, Roche disclosed the first results for its TIGIT-targeting compound, called tiragolumab.
Sanofi's hemophilia drug comes into focus as delays hit a
(8 days ago) People with severe hemophilia A typically use injectable drugs multiple times a week to replace the clotting proteins they lack. Sanofi has been developing a longer-lasting version, meant to be used once weekly or less, that it acquired when it bought Bioverativ in 2018.. Last year it produced the first significant results from that program, a study that looked at 16 men with …
Gilead pays up to retain rights to Arcus cancer drugs
(Just Now) The deal is the latest in a long-running effort by Gilead, which made its name in antiviral drugs, to expand into oncology. The company has won approvals for three cancer drugs in the past four years, but sales of its HIV drugs still dwarf that of its oncology business.
Esperion lays off nearly half its workforce as heart drug
(7 days ago) One reason is the availability of potent injectable drugs like Amgen's Repatha and Sanofi and Regeneron's Praluent, each of which are approved for some of the same patients. While these so-called PCSK9 inhibitors were expensive and tough to get when first launched, price cuts have since made them more accessible.
A worrisome side effect stalls a closely watched multiple
(7 days ago) These drugs latch onto BCMA and a target on immune cells called CD3. Drugmakers hope they'll be nearly as effective as cell therapy, but safer and easier to distribute — particularly among the community doctors that treat a majority of multiple myeloma patients. Regeneron, Amgen, J&J and AbbVie, along with Pfizer, each have similar BCMA
White House backs importing drugs from abroad BioPharma Dive
(9 days ago) Dive Brief: The Trump administration on Wednesday proposed allowing the importation of lower-priced drugs from foreign countries in its latest bid to lower patient out-of-pocket costs. The proposal rests on the belief that manufacturers would offer imported drugs at a lower price if they sold them under a different National Drug Code than
Why some new drugs are truly earning the 'innovative
(Just Now) In short, innovative drugs are drugs that introduce a new mechanism of action (MOA), as well as drugs that treat diseases where there have historically been limited treatment options, such as orphan diseases, or drugs in a new therapeutic area where there has not been any progress for years. 'Me-too' drugs and the possibility frontier
Mirati gives first look at KRAS drug combination in lung
(5 days ago) A larger Phase 2 trial of the two drugs together in previously untreated advanced lung cancer is ongoing and data is expected in the second half of next year. For Mirati, the update comes amid significant upheaval in the company's leadership.
FDA seeks to make more drugs available over the counter
(8 days ago) All drugs changed to over-the-counter products would still need to meet the FDAs "evidentiary standard" for nonprescription drugs, Gottlieb said. As the FDA moves to approve more prescription drugs for over-the-counter sale, they will also be ensuring safety and effectiveness through robust scientific review of data on these medications.
8 key clinical trials to watch for the rest of 2021
(3 days ago) The first half of 2021 was historic for biotech. The Food and Drug Administration cleared the first new Alzheimer's drug in nearly two decades, a controversial decision with far-reaching consequences. Multiple effective coronavirus vaccines and antibody drugs helped bring the pandemic under control in the U.S., while the first-ever treatment for a common genetic driver …
AstraZeneca builds case for long-acting COVID-19 drug, but
(6 days ago) AstraZeneca's antibody also lasts at least six months and can be administered through a single intramuscular injection. In its announcement, for example, AstraZeneca called its drug the "only long-acting antibody combination shown to prevent and treat COVID-19." Yet the other marketed COVID-19 antibody drugs each have some of those elements.
Sanofi handed payers nearly $12B in drug rebates last year
(Just Now) To Sanofi's point, though, diabetes drugs like Lantus are frequently subject to considerable rebating in the U.S. The drugmaker claims the average net price across its insulin portfolio is 25% less than it was in 2012 even as list prices have more than doubled during that same time span.
Amgen pays $900M for Teneobio and bets bigger on next-gen
(3 days ago) Amgen has agreed to acquire privately held biotech Teneobio for as much as $2.5 billion in a deal meant to broaden the big biotech’s ability to develop antibody drugs for cancer and potentially other diseases. Per deal terms, Amgen will pay $900 million in cash for Teneobio and could add another $1.6 billion in downstream payments if certain
New estimate puts cost to develop a new drug at $1B
(5 days ago) U.S. biopharmaceutical companies spent about $1 billion to bring each of their new drugs to market between 2009 and 2018, according to a new analysis published in JAMA on Tuesday.. The analysis, which accounts for projects that failed in clinical development, confirms similar numbers that have been published in the past, although it rebuts a more recent finding putting …
AstraZeneca spins out new biotech, shedding autoimmune drugs
(Just Now) Dive Brief: MedImmune, AstraZeneca plc's biologics R&D unit, will spin out six experimental drugs into a standalone biotech, aiming to speed development of assets that fall outside of its core areas of research. Viela Bio will launch with a sizable war chest of $250 million, funded by a group of outside investors led by Chinese firm Boyu Capital.
A three-decade monopoly: how Amgen built a patent thicket
(Just Now) Biologic drugs are more complex than chemical pills, too, allowing their makers to construct denser thickets that keep low-cost competitors at bay for longer, as was the case with Enbrel. How Amgen built a 'patent thicket' around Enbrel.
NASH drugs come into focus as field awaits late-stage data
(1 days ago) NASH drugs come into focus as field awaits late-stage data. For drugmakers searching to find a treatment for non-alcoholic steatohepatitis, a chronic liver condition commonly known as NASH, questions still outnumber answers. What's become clear, however, is that a therapeutic solution will require several complementary approaches, rather than a
Novo to acquire Dicerna for more than $3B amid RNA drug
(3 days ago) The acquisition is the latest validation of so-called RNA interference drugs, a drugmaking method that involves silencing genes before they can make harmful proteins. The field, based on scientific work that won a Nobel Prize in 2006, drew significant interest from pharmaceutical companies many years ago because of its potential to create drugs
Biogen chases rivals with another bet on emerging class of
(1 days ago) The licensing deal is the latest indication of the industry's interest in aiming drugs known as BTK inhibitors at autoimmune diseases like MS. Sanofi, Roche and Merck KGaA are each testing BTK inhibitors in Phase 3 trials, and Biogen completed an early-stage study of a similar drug last year.
Novartis sells US rights to 3 COPD drugs BioPharma Dive
(3 days ago) Novartis' drugs, all inhalation powders, brought in a combined $169 million during the third quarter, according to Novartis' most recent quarterly filing, though they currently represent less than half of the company's total respiratory earnings, which hit …
Global Blood takes on more sickle cell drugs through
(4 days ago) Currently, just a small number of drugs are approved to treat sickle cell, with one of the newest, Oxbryta, coming from Global Blood. Tuesday's deal further expands Global Blood's work, giving it access to research programs that harness new ways to stop cells from sickling as well as reduce inflammation and oxidative stress .
Alkermes prepares for uncertain launch as FDA finally
(1 days ago) To Alkermes, Lybalvi also represents an attractive option for patients dealing with the weight gain and metabolic side effects known to occur from drugs like Zyprexa. Lybalvi works, in part, by regulating the part of the brain that signals pleasure when a person eats, and late-stage clinical testing found that people who took it as opposed to
Drug price restraints dropped as Biden prioritizes other
(8 days ago) The announcement Thursday likely ends all hope of enacting a law authorizing the federal government to negotiate, and potentially reduce, prescription drug prices. But smaller measures could still make it into the package, such as provisions that target Medicare payments for biologic drugs administered in healthcare facilities.
Novartis finalizes deal to make new heart drug widely
(6 days ago) Persistently high cholesterol is a major risk factor, particularly in people who have already had a heart attack or stroke. Clinical testing showed Leqivo could dramatically lower cholesterol in people who are already taking statins or statins together with other lipid-lowering drugs.
Alnylam wins US approval for its third rare disease drug
(1 days ago) Dive Insight: In little more than two years, Alnylam has shepherded three medicines to market, the products of groundbreaking science that "silences" genes to halt disease. The first of these so-called RNA interference drugs, Onpattro, cleared the FDA in August 2018. The Cambridge, Massachusetts-based biotech then won approval for the second, Givlaari, in November 2019.
Looking ahead at orphan drugs' future: More breakthroughs
(4 days ago) The three drugs highlight the revenue promise of orphan drugs. Evaluate Pharma, an analysis firm, predicts worldwide orphan drug sales will grow to $178 billion, from $97 billion in 2014. This projected growth is twice as fast as that of the overall drug market, propelling orphan drugs to just over 20% of global prescription sales in 2020.
5 FDA approval decisions to watch in the fourth quarter
(7 days ago) In the study supporting Abecma's approval, for instance, 72% of patients responded to treatment and a third of them went into remission. Though it's difficult to compare drugs across trials, 98% of patients in J&J and Legend's key study responded, and 80% were in remission a year and a half after treatment. The FDA is expected to make a decision by Nov. 29, which could kick off …
AstraZeneca strikes deal with university spinoff to turn
(4 days ago) Rather than use mRNA, VaxEquity is focusing on self-amplifying RNA, which it claims could allow for lower or less-frequent dosing of drugs and vaccines. Under the companies' collaboration, AstraZeneca will make an undisclosed investment into VaxEquity as well as support it with research and development funding.