Pharmaceutical - Pharma Rep Focus

Martin Shkreli runs afoul of FTC for potentially skirting lifetime pharmaceutical industry ban

Fierce Pharma

JANUARY 20, 2023

Martin Shkreli runs afoul of FTC for potentially skirting lifetime pharmaceutical industry ban fkansteiner Fri, 01/20/2023 - 15:34

Pharmaceutical

Scilex's Semnur Pharmaceuticals to go public through $2.5B SPAC merger as it advances sciatica prospect

Fierce Pharma

SEPTEMBER 3, 2024

Semnur Pharmaceuticals, which is working on a non-opioid prospect for sciatica, has agreed to merge with special purpose acquisition company Denali Capital Acquisition Corp. Semnur Pharmaceuticals is following in its parent company Scilex's footsteps with a special purpose acquisition company (SPAC) merger.

Prospecting

Prospecting Pharmaceutical Specialization

ARS Pharmaceuticals hit with surprise FDA rejection of Neffy, its nasal spray epinephrine alternative

Fierce Pharma

SEPTEMBER 20, 2023

ARS Pharmaceuticals learned that lesson the hard way, as the FDA issued a surprise rejection of its anaphylaxis nasal spray Neffy. Positive FDA advisory committee votes aren’t always a blueprint for approval. Positive FDA advisory committee votes aren’t always a blueprint for approval.

FDA

FDA Pharmaceutical

Delaware's Marlex Pharmaceuticals recalls 2 batches of heart failure drug after labeling mix-up

Fierce Pharma

SEPTEMBER 1, 2023

Marlex Pharmaceuticals of New Castle, Delaware, is recalling two lots of digoxin tablets at the 0.125-mg and 0.25-mg When it comes to heart failure medication, a labeling mix-up can have dire consequences. mg dose, and vice versa.

Pharmaceutical

Pharmaceutical Medical

Pfizer moves to settle more than 10,000 Zantac cases in state courts: Bloomberg

Fierce Pharma

MAY 8, 2024

Following the lead of French pharmaceutical giant Sanofi, Pfizer has agreed to settle more than 10,000 personal-injury claims from users of heartburn drug Zantac, resolving litigation in several U. state courts, according to Bloomberg.

Leads

Leads Pharmaceutical

It's a monster MASH for Madrigal as Rezdiffra has caught on in a flash

Fierce Pharma

OCTOBER 31, 2024

Forget about the “bumpiness” analysts expected from Madrigal Pharmaceuticals’ launch of potentia | Forget about the “bumpiness” analysts expected from Madrigal Pharmaceuticals’ launch of potential blockbuster Rezdiffra.

Sales

Sales Pharmaceutical Marketing

Novartis, Apellis drop dueling datasets as they race for approval in rare form of kidney disease

Fierce Pharma

OCTOBER 28, 2024

Novartis and Apellis Pharmaceuticals have rolled out detailed data on iptacopan and pegcetacoplan, respectively, as they race for the prize in a type of rare kidney disease. Novartis and Apellis dropped new data on their respective meds, iptacopan and pegcetacoplan, in the rare kidney disease C3 glomerulopathy.

Pharmaceutical

Teva weighs sale of $2B API business as CEO Richard Francis embarks on 'Pivot to Growth' strategy: reports

Fierce Pharma

JULY 6, 2023

Less than two months into its "Pivot to Growth" strategy under a new CEO, Israeli-American generics giant Teva Pharmaceutical could be weighing a major shake-up of its key drug ingredients business | Teva is looking at strategic options for its active pharmaceutical ingredient unit, with a potential sale on the table, BNN Bloomberg and Benzinga (..)

Sales

Sales Pharmaceutical

European Pharmaceutical Review Issue 5 2024

European Pharmaceutical Review

NOVEMBER 21, 2024

The post <em>European Pharmaceutical Review </em> Issue 5 2024 appeared first on European Pharmaceutical Review. Register your details to access this exclusive content!

Pharmaceutical

Pharmaceutical Consulting Manufacturing

Vertex, CRISPR's gene-editing therapy Casgevy wins early FDA nod to treat beta thalassemia

Fierce Pharma

JANUARY 16, 2024

Vertex Pharmaceuticals and CRISPR Therapeutics have scored an FD | Vertex Pharmaceuticals and CRISPR Therapeutics have scored an FDA approval for their gene-editing therapy Casgevy (exa-cel) to treat transfusion-dependent beta thalassemia (TDT). The approval came more than two months ahead of the FDA's March 30 decision date.

FDA

FDA Pharmaceutical

J&J and Roche are the strongest companies in the biopharma industry, says S&P Global

Fierce Pharma

AUGUST 14, 2024

Johnson & Johnson and Roche are at the top of S&P Global’s pharmaceutical industry power ratings, which assess the strength of the world’s top 17 drugmakers. | Johnson & Johnson and Roche are at the top of S&P Global’s pharmaceutical industry power ratings, which assess the strength of the world’s top 17 drugmakers.

Biopharma

Biopharma Pharmaceutical

Amneal agrees to $272.5M settlement to resolve opioid lawsuits

Fierce Pharma

MAY 6, 2024

Amneal Pharmaceuticals has agreed to pay $272.5 million to settle approximately 900 lawsuits brought by state, local and Native American jurisdictions claiming that the New Jersey generics producer | Amneal Pharmaceuticals has agreed to pay $272.5

Pharmaceutical

Orphan drug market to reach $270B by 2028, led by J&J, Vertex and Roche: Evaluate

Fierce Pharma

APRIL 23, 2024

The orphan drug sector has long been clearing growth in the larger pharmaceutical market with booming sales. | The orphan drug sector has long been clearing growth in the larger pharmaceutical market with booming sales.

Marketing

Marketing Sales Pharmaceutical

Otsuka pulls plug on Alzheimer's agitation drug after 2nd failed trial

Fierce Pharma

MAY 22, 2024

Otsuka Pharmaceutical is packing up an Alzheimer’s disease med after a phase 3 study failed to move the needle on m | Otsuka Pharmaceutical is packing up an Alzheimer’s disease med after a phase 3 study failed to move the needle on measures of agitation associated with dementia.

Pharmaceutical

House lawmaker brings FDA into biosecurity crackdown on China

Fierce Pharma

MAY 8, 2024

the House Committee on Oversight and Accountability chairman argued that China’s influence over global pharmaceutical supply chains constitutes an act of economic warfare against the United States. Amid a U.S. | In a letter to FDA Commissioner Robert Califf, M.D.,

FDA

FDA Pharmaceutical

As Vertex and CRISPR build out Casgevy launch, doctor sees strong demand and warns of possible supply hitches

Fierce Pharma

DECEMBER 21, 2023

As Vertex Pharmaceuticals and CRISPR Therapeutics lay the groundwork for the launch of their CRISPR-based gene-editing therapy Casgevy, one doctor who treats sickle cell disease patients is already | As Vertex Pharmaceuticals and CRISPR Therapeutics lay the groundwork for the launch of their world-first CRISPR-based gene therapy Casgevy, one doctor (..)

Doctors

Doctors Pharmaceutical Patients

Jazz's almost-withdrawn lung cancer drug Zepzelca extends life on top of Roche's Tecentriq

Fierce Pharma

OCTOBER 15, 2024

Jazz Pharmaceuticals’ Zepzelca, once on the brink of a market withdrawal, has returned with new trial results showing it could prolong patients’ lives in extensive-stage small cell lung cancer (ES- | Jazz Pharmaceuticals’ Zepzelca, once on the brink of a market withdrawal, has returned with new trial results showing it could prolong patients’ lives (..)

Pharmaceutical

Pharmaceutical Marketing Patients

A closer look at 'friend-shoring' and the drug shortage challenge

Fierce Pharma

JUNE 21, 2024

In this week’s episode of “The Top Line,” Fierce Pharma’s Zoey Becker sits down with Bobby Sheng, the CEO of Bora Pharmaceuticals, to discuss the concept of “friend-shoring” in drug manufacturing.<

Manufacturing

Manufacturing Pharmaceutical

More turbulence at Aurinia as autoimmune drugmaker lays off 45% of workforce

Fierce Pharma

NOVEMBER 7, 2024

After an activist investor revolted against the leadership team at Aurinia Pharmaceuticals, the CEO in question is resorting to restructuring.

Pharmaceutical

Pfizer's cost-cutting campaign hits Sandwich site in UK, where 500 workers will lose jobs

Fierce Pharma

NOVEMBER 14, 2023

Pfizer plans to cut approximately 500 roles and ax its Pharmaceutical Sciences Small Molecule capabilities at its site in Sandwich in Kent in the U.K. Earlier this month, Pfizer’s $3.5 billion cost-cutting campaign crossed overseas to Ireland. Now, just a week later, Pfizer is announcing hundreds more job cuts in the U.K.

Pharmaceutical

Johnson & Johnson accuses former employee of taking thousands of files to new role at Pfizer

Fierce Pharma

MARCH 20, 2024

As two of the world’s largest pharmaceutical companies, Johnson & Johnson and Pfizer have long been rivals in various therapeutic areas. | The company is accusing former employee Andrew Brackbill of downloading thousands of confidential strategy-related files before leaving for rival Pfizer.

Pharmaceutical

Vanda secures FDA approval for Fanapt to treat bipolar I, 15 years after schizophrenia nod

Fierce Pharma

APRIL 3, 2024

Fifteen years after gaining its first FDA approval for Fanapt (iloperidone) to treat schizophrenia, Vanda Pharmaceuticals has scored again with the same antipsychotic drug. The FDA has signed off on Fanapt tablets to treat adults with manic or mixed episodes associated with bipolar I disorder.

FDA

FDA Pharmaceutical

FDA nod for Azurity's Danziten will allow patients to take leukemia med without fasting

Fierce Pharma

NOVEMBER 15, 2024

Azurity Pharmaceuticals has earned an FDA approval for Danziten, a new formulation of Novartis’ chronic myeloid leukemia (CML) blockbuster Tasigna.

FDA

FDA Patients Pharmaceutical

Vertex clinches Trikafta and other cystic fibrosis drug reimbursement deal in England

Fierce Pharma

JUNE 21, 2024

Cystic fibrosis (CF) patients and their families in England can rest a little easier this week, thanks to an extended long-term reimbursement deal inked by Vertex Pharmaceuticals and the country’s | Cystic fibrosis (CF) patients and their families in England can rest a little easier this week, thanks to an extended long-term reimbursement deal inked (..)

Pharmaceutical

Pharmaceutical Patients

Alnylam CEO touts 'big-win scenario' for Amvuttra in closely watched heart disease trial

Fierce Pharma

JUNE 24, 2024

In one of the most closely watched biotech trial readouts of the year, Alnylam Pharmaceuticals said its RNA interference drug reduced the risk of death or recurrent cardiovascular events in patient | In one of the most closely watched biotech trial readouts of the year, Alnylam Pharmaceuticals said its RNA interference drug reduced the risk of death (..)

Pharmaceutical

Pharmaceutical Patients

Amgen expands pact with Amazon to usher drug manufacturing into the AI era

Fierce Pharma

NOVEMBER 29, 2023

. | Amgen is growing its decade-old collaboration with Amazon Web Services—a widely used cloud platform—to create generative artificial intelligence that the companies aim to use to increase the manufacturing throughput of pharmaceuticals.

Manufacturing

Manufacturing Medicine Pharmaceutical

AbbVie flexes litigation muscle with Rinvoq patent lawsuit against Sandoz, other generic players

Fierce Pharma

NOVEMBER 22, 2023

In a lawsuit filed in Delaware federal court Monday, AbbVie accused Sandoz, Hetero Labs, Aurobindo Pharma, Intas Pharmaceuticals and Sun Pharmaceutical of trying to sidestep dozens of patents protecting Rinvoq through the next decade.

Pharmaceutical

Pharmaceutical Pharma Marketing

JPM24, Day 3: Alkermes enters new phase after busy year

Fierce Pharma

JANUARY 3, 2024

Morgan Healthcare Conference, attendees will get a chance to hear from AbbVie, Amarin and several other pharmaceutical companies. Morgan Healthcare Conference moves into its third day, we're covering the latest developments here. | On Wednesday at the the J.P.

Healthcare

Healthcare Healthcare Pharmaceutical

Vanda, despite FDA rejection, swats down another buyout bid from Cycle

Fierce Pharma

OCTOBER 14, 2024

The FDA’s rejection of Vanda Pharmaceuticals’ stomach disease candidate has done little to dampen the enthusiasm of England’s Cycle Pharmaceuticals to acquire the Washington D.C.-based based company. |

FDA

FDA Pharmaceutical Pharma

Charles River snags clearance to produce Vertex and CRISPR's Casgevy from Tennessee plant

Fierce Pharma

DECEMBER 18, 2023

Following a string of approvals in the United States and beyond, Vertex Pharmaceuticals continues to build out its manufacturing network for the world’s first CRISPR-based gene therapy, Casgevy.

Networking

Networking Manufacturing Pharmaceutical

US Supreme Court rejects Vanda's bid to revive patents on sleep disorder drug Hetlioz

Fierce Pharma

APRIL 22, 2024

The prospects for Vanda Pharmaceuticals’ 10-year-old circadian rhythm drug Hetlioz have grown that much dimmer after the U.S. | The prospects for Vanda Pharmaceuticals’ 10-year-old circadian rhythm drug Hetlioz have grown that much dimmer after the U.S.

Prospecting

Prospecting Pharmaceutical

Vertex taps Lonza to help produce global supply of cutting-edge CRISPR therapy Casgevy

Fierce Pharma

SEPTEMBER 24, 2024

With the launch of Casgevy gaining momentum, Vertex Pharmaceuticals is adding another link to its gene-editing therapy supply chain. Vertex has inked a long-term supply agreement with Swiss CDMO Lonza to crank out global commercial supply of Casgevy.

Manufacturing

Manufacturing Pharmaceutical

In wake of Reata buyout, Biogen's key launch Skyclarys passes muster in EU

Fierce Pharma

FEBRUARY 12, 2024

billion buyout of rare disease specialist Reata Pharmaceuticals, the companies’ blockbuster bid for Reata’s Friedreich’s ataxia (FA) drug Skyclarys is starti | Roughly half a year after Biogen’s $7.3 Roughly half a year after Biogen’s $7.3

Pharmaceutical

After Roche breakup, Blueprint Medicines finds Gavreto a new home at Rigel

Fierce Pharma

FEBRUARY 22, 2024

owner in Rigel Pharmaceuticals. As Roche officially abandoned cancer drug Gavreto, its former partner Blueprint Medicines has found the RET inhibitor a new owner in the U.S. | As Roche officially abandoned cancer drug Gavreto, its former partner Blueprint Medicines has found the RET inhibitor a new U.S.

Medicine

Medicine Pharmaceutical

Amid GLP-1 craze, Novo and Mylan ink patent settlement in Ozempic case

Fierce Pharma

OCTOBER 7, 2024

Mylan Pharmaceuticals and Novo Nordisk have reached a confidential settlement in a patent lawsuit tied to generic Ozempic, also known as semaglutide, India’s Natco Pharma said. With a new patent settlement, generic partners Mylan and Natco have cleared one hurdle to a potential U.S.

Pharma

Pharma Pharmaceutical

Proposed chemical ban would cause EU drug manufacturing to 'grind to a halt,' trade group warns

Fierce Pharma

SEPTEMBER 29, 2023

A proposed restriction on the use of fluorinated substances in Europe would have an “irredeemable impact” on the continent’s life sciences sector, the European Federation of Pharmaceutical Industri | A proposed restriction on the use of fluorinated substances in Europe would have an “irredeemable impact” on the continent’s life sciences sector, the (..)

Manufacturing

Manufacturing Pharmaceutical

Roche's Vabysmo shows potential to treat eye disorder common in Asia

Fierce Pharma

NOVEMBER 21, 2024

Few pharmaceutical products have taken the market by storm like Roche’s Vabysmo. Interim results from a late-stage trial of Roche's Vabysmo on Asian patients with polypoidal choroidal vasculopathy suggest that the injected treatment is effective.

Pharmaceutical products

Pharmaceutical products Pharmaceutical Marketing Patients

After 17-year courtship, Sun and Taro finally agree on $348M buyout

Fierce Pharma

JANUARY 18, 2024

It took 17 years for Sun Pharmaceutical and Taro Pharmaceutical to finally tie the knot. | It took 17 years for Sun Pharmaceutical and Taro Pharmaceutical to finally tie the knot. The deal nets out to $348 million for a 48% premium on Taro's share price of $29.

Pharmaceutical

Decades-long regulatory odyssey ends with FDA nod for Fabre-Kramer's depression med Exxua

Fierce Pharma

SEPTEMBER 28, 2023

Fabre-Kramer Pharmaceuticals' major depressive disorder (MDD) drug gepirone has been rejected by the FDA not once, not twice, but three times since the turn of the millennium. Fabre-Kramer's Exxua suffered three prior FDA rejections before scoring an FDA approval for major depressive disorder last week.

FDA

FDA Pharmaceutical

PhRMA seeks to revive Medicare price negotiations lawsuit, blasts Biden's request for IRA expansion

Fierce Pharma

MARCH 8, 2024

As President Joe Biden doubles down on the price negotiation meas | As President Joe Biden doubles down on the price negotiation measures in the Inflation Reduction Act, prominent industry lobbying group the Pharmaceutical Research and Manufacturers of America isn’t letting its legal challenge go down without a fight.

Pharmaceutical research

Pharmaceutical research Manufacturing Pharmaceutical

As Stelara cliff looms, J&J expects 25 blockbuster drugs to drive future sales growth

Fierce Pharma

DECEMBER 5, 2023

As Johnson & Johnson places a magnifying glass on its pharmaceutical business, the focus for the remainder of the decade rests on the shoulders of some 25 new and upcoming drugs.

Sales

Sales Pharmaceutical

Amylyx to pull failed ALS drug Relyvrio from market, cut 70% of staffers

Fierce Pharma

APRIL 4, 2024

Amylyx Pharmaceuticals is keeping a promise by pulling the amyotrophic lateral sclerosis (ALS) therapy Relyvrio off the market after the drug failed in a confirmatory trial. Amylyx is keeping a promise by pulling the amyotrophic lateral sclerosis (ALS) therapy Relyvrio off the market after the drug failed in a confirmatory trial.

Marketing

Marketing Pharmaceutical

Amid FTC crackdown, judge says Teva inhaler patents are 'improperly listed' in FDA Orange Book

Fierce Pharma

JUNE 12, 2024

The ruling came in Teva's case against Amneal Pharmaceuticals, which is seeking to launch a generic version of the drug. . | A federal judge in New Jersey ruled that five of Teva’s patents on the metered dose inhaler for its asthma med ProAir HFA are “improperly listed” in the FDA’s Orange Book.

FDA

FDA Pharmaceutical

Lexicon to lay off 50% of field force as it prioritizes heart failure drug, potential US diabetes launch

Fierce Pharma

AUGUST 13, 2024

Despite winning an FDA approval in 2023 and gaining clarity in May on the regulatory path forward for its Type 1 diabetes prospect sotagliflozin, Lexicon Pharmaceuticals hasn’t had an easy go of it | As part of a restructuring initiative, Lexicon Pharmaceuticals will lay off more than 75 staffers, or approximately 50% of its current field force, by (..)

Prospecting

Prospecting FDA Pharmaceutical

Martin Shkreli runs afoul of FTC for potentially skirting lifetime pharmaceutical industry ban

Scilex's Semnur Pharmaceuticals to go public through $2.5B SPAC merger as it advances sciatica prospect

Trending Sources

ARS Pharmaceuticals hit with surprise FDA rejection of Neffy, its nasal spray epinephrine alternative

Delaware's Marlex Pharmaceuticals recalls 2 batches of heart failure drug after labeling mix-up

Pfizer moves to settle more than 10,000 Zantac cases in state courts: Bloomberg

It's a monster MASH for Madrigal as Rezdiffra has caught on in a flash

Novartis, Apellis drop dueling datasets as they race for approval in rare form of kidney disease

Teva weighs sale of $2B API business as CEO Richard Francis embarks on 'Pivot to Growth' strategy: reports

European Pharmaceutical Review Issue 5 2024

Vertex, CRISPR's gene-editing therapy Casgevy wins early FDA nod to treat beta thalassemia

J&J and Roche are the strongest companies in the biopharma industry, says S&P Global

Amneal agrees to $272.5M settlement to resolve opioid lawsuits

Orphan drug market to reach $270B by 2028, led by J&J, Vertex and Roche: Evaluate

Otsuka pulls plug on Alzheimer's agitation drug after 2nd failed trial

House lawmaker brings FDA into biosecurity crackdown on China

As Vertex and CRISPR build out Casgevy launch, doctor sees strong demand and warns of possible supply hitches

Jazz's almost-withdrawn lung cancer drug Zepzelca extends life on top of Roche's Tecentriq

A closer look at 'friend-shoring' and the drug shortage challenge

More turbulence at Aurinia as autoimmune drugmaker lays off 45% of workforce

Pfizer's cost-cutting campaign hits Sandwich site in UK, where 500 workers will lose jobs

Johnson & Johnson accuses former employee of taking thousands of files to new role at Pfizer

Vanda secures FDA approval for Fanapt to treat bipolar I, 15 years after schizophrenia nod

FDA nod for Azurity's Danziten will allow patients to take leukemia med without fasting

Vertex clinches Trikafta and other cystic fibrosis drug reimbursement deal in England

Alnylam CEO touts 'big-win scenario' for Amvuttra in closely watched heart disease trial

Amgen expands pact with Amazon to usher drug manufacturing into the AI era

AbbVie flexes litigation muscle with Rinvoq patent lawsuit against Sandoz, other generic players

JPM24, Day 3: Alkermes enters new phase after busy year

Vanda, despite FDA rejection, swats down another buyout bid from Cycle

Charles River snags clearance to produce Vertex and CRISPR's Casgevy from Tennessee plant

US Supreme Court rejects Vanda's bid to revive patents on sleep disorder drug Hetlioz

Vertex taps Lonza to help produce global supply of cutting-edge CRISPR therapy Casgevy

In wake of Reata buyout, Biogen's key launch Skyclarys passes muster in EU

After Roche breakup, Blueprint Medicines finds Gavreto a new home at Rigel

Amid GLP-1 craze, Novo and Mylan ink patent settlement in Ozempic case

Proposed chemical ban would cause EU drug manufacturing to 'grind to a halt,' trade group warns

Roche's Vabysmo shows potential to treat eye disorder common in Asia

After 17-year courtship, Sun and Taro finally agree on $348M buyout

Decades-long regulatory odyssey ends with FDA nod for Fabre-Kramer's depression med Exxua

PhRMA seeks to revive Medicare price negotiations lawsuit, blasts Biden's request for IRA expansion

As Stelara cliff looms, J&J expects 25 blockbuster drugs to drive future sales growth

Amylyx to pull failed ALS drug Relyvrio from market, cut 70% of staffers

Amid FTC crackdown, judge says Teva inhaler patents are 'improperly listed' in FDA Orange Book

Lexicon to lay off 50% of field force as it prioritizes heart failure drug, potential US diabetes launch

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