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The Subject Expert Committee (SEC), which advises the national drug regulator on matters related to approval of new drugs and medical devices and clinical trials, has recommended grant of market authorisation for Telangana-based MSN Laboratories for sleep disorder drug Pitolisant tablets.
The Indianapolis drugmaker is now worth more than $500 billion, higher than any other pharmaceutical company, as analysts project lucrative markets for its obesity and Alzheimer's drugs.
The osteoporosis market is expected to grow at a compound annual growth rate of 5.4% The osteoporosis market is expected to grow at a compound annual growth rate of 5.4%
The Future of Generic Drug Development: Opportunities and Challenges for Emerging Markets As the global healthcare landscape continues to evolve, emerging markets are playing an increasingly important role in shaping the future of generic drug development. Share your thoughts in the comments below!
As folks steeped in the world of generic drugs And Hatch-Waxman know, theres a lot that happens before FDA can take action on an ANDA. Leading FDAs implementationof the Drug Competition Action Plan (DCAP). And DPD was a significant piece of that puzzle. facilitating the twice annual updates to the Off-Patent, Off-Exclusivity List ).
As such, the SLE and LN marketplace is dominated by generics, and GSK’s Benlysta and AstraZeneca’s Saphnelo are the only drugs that have gained marketing approval specifically for SLE in more than 50 years. In previous years, Benlysta has managed to grow the lupus market in terms of value, having generated approximately $492.9m
Negative drug results cost AbbVie billions of dollars in market value and convinced analysts that Bristol Myers had placed a better bet in buying Karuna Therapeutics.
Talks of a bear market in the biotech sector do not seem to pass, with news of companies falling into administration and layoffs becoming a recurrence. Just last week, trading for 4D Pharma , a British biotech, was suspended on the London Stock Exchange’s Alternative Investment Market , and the company will be delisted from NASDAQ on July 7.
A key regulatory committee sided against the drug this summer. But an appeal from Eisai appears to have worked, teeing Leqembi up for authorization in a major market.
A new fast track designation allows Lilly to begin the process of seeking approval of tirzepatide for obesity, though the drug will need to succeed in a second trial to get to market.
The company said data for its Wegovy competitor was promising enough to move the drug into late-stage testing, triggering a stock jump that added billions to Amgen’s market value.
The top 20 biopharmaceutical companies demonstrated resilience during the second quarter (Q2) of 2024 as global markets and investor optimism improved with anticipation of a potential interest rate cut from the US Federal Reserve.
The first-line approval of Padcev together with Keytruda is viewed as important to expanding the drug’s market, and comes weeks after Pfizer agreed to buy Seagen for $43 billion.
The well-funded startup says drugs AbbVie abandoned last year could form a combination regimen with “superior efficacy” to Vertex’s market-leading medicines.
Sanofi and its development partner, Sobi, claim the drug’s once-a-week dosing, and its effect on blood-clotting protein levels, will help it compete in the crowded market for hemophilia A treatments.
Beginning a high-stakes advisory meeting, CDER head Patrizia Cavazzoni said that Covis Pharma’s drug is ineffective and should not remain on the market.
“What we’re experiencing now is the aftershock of the party that went on for the last three years,” said Ovid CEO Jeremy Levin in a BioPharma Dive panel that included former Sage head Jeff Jonas and biotech entrepreneur Greg Verdine.
The positive results could help Novartis secure approval for earlier use of the radiopharmaceutical drug Pluvicto, potentially broadening the number of eligible patients by several times the current market.
drugmaker withdrew the multiple myeloma drug from the U.S. market because of negative data, new study results might crack open the door to a relaunch. One year after the U.K.
According to GlobalData’s recent Niemann-Pick Type C (NPC): Opportunity Analysis and Forecast to 2031 report, the NPC market is expected to see significant growth during 2021–31. This sales growth will be in line with a steadily increasing disease prevalence and the entrance of novel agents into the market.
Lotus Pharmaceuticals and Teraju Pharma have entered a strategic partnership to market Lotus’s products in a range of therapeutic areas in Malaysia. Teraju Pharma will be responsible for marketing and promoting the products using its relationships and infrastructure.
Despite this, specialty generics are expected to be the domain of a handful of companies with the necessary manufacturing capabilities and legal backing needed for entering the market. Specialty drugs are most used to treat different cancers, rheumatoid arthritis, and multiple sclerosis. The only way forward for generics producers.
These agreements have been particularly propelled by the recent rise in inflationary pressures and pharmaceutical market instability, pushing healthcare systems to find new ways to reduce risks associated with new drugs. Thus, a higher risk score reflects a more hostile market access environment and drug launch in a geographical area.
The European Commission (EC) has granted marketing authorisation for Sandoz’s biosimilar Hyrimoz (adalimumab) citrate-free high-concentration formulation (HCF). With eight marketed biosimilars, Sandoz is offering the broadest biosimilar portfolio and is the leading biosimilars company in Europe, with more than two decades of experience.
In that trial, the drug demonstrated positive signs of clinical activity – all patients receiving VK2735 reported a loss in mean body weight. According to Sara Reci, analyst at GlobalData, many late-stage pipeline products for obesity emulate what is currently on the market, and employ the GLP-1 mechanism of action.
The Unseen Heroes of Generic Drugs: Stability Testing 101 As a consumer, have you ever stopped to think about the rigorous process that goes into bringing a generic version of your favorite medication to market? For generic drug manufacturers, stability testing is a critical step in the development process.
Treatment is now mostly of infants newly diagnosed with spinal muscular atrophy, as many of those previously eligible either already received Zolgensma or other drugs from Biogen and Roche.
The subsidiary, called Cordavis, will work directly with manufacturers to market or co-produce low-cost biologic drugs, starting with Novartis’ Humira copy.
Private biotech company acquisitions are on their fastest pace in years, a trend some in the industry say is driven by the abundance of mature, but not yet public, drug startups.
Goldman Sachs and Eli Lilly are among those backing the startup, which claims its prospect could be more potent than the myelofibrosis therapies that have come to market in recent years.
The Subject Expert Committee (SEC) which advises the national drug regulator on drug approvals and clinical trials has recommended grant of permission to drug major Astrazeneca for import and marketing of two strengths of anti-hyperkalaemia therapy drug Lokelma (sodium zirconium cyclosilicate for oral suspension).
Maximizing Patent Protection: Strategies for Pharmaceutical Marketers As a pharmaceutical marketer, you know how crucial it is to protect your patented drug'smarket share. This exclusivity is a result of the patent protection granted to the drug's developer. Read the full article here: [link]
For the first time in years, biotechs no longer have an easy path onto Wall Street, a market reversal that could change what the next generation of young drugmakers looks like.
The results have led Amylyx to pause promotion of Relyvrio and potentially pull it from the market in the coming weeks, a major blow to the company and ALS patients.
Results from the head-to-head study showed treatment with Zepbound resulted in 47% greater relative weight loss than Wegovy, a finding that could advantage Lilly in the companies’ market competition.
Apellis’ Syfovre is the first marketed treatment for geographic atrophy, a common and irreversible eye condition. But questions linger about its benefit and safety.
The top 20 biopharmaceutical companies demonstrated signs of recovery during the third quarter (Q3) of 2024 as investor optimism improved following the interest rate cuts by the US Federal Reserve in September 2024.
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