Search Results for “vaccine” – Page 39 – media

Senate Democrats press Sanofi and AZ for answers as ‘unprecedented’ demand spurs shortage of RSV antibody Beyfortus

The shortage of Sanofi and AstraZeneca’s new respiratory syncytial virus (RSV) antibody Beyfortus continues to confound doctors and patients, with the Centers for Disease Control and Prevention (CDC) last week fast-tracking tens of thousands of extra doses into circulation to deal with a tough RSV season. Now, several Senate Democrats are pressing the drugmakers to get to the bottom of the issue. In a letter sent to the drugmakers Friday, Sen. Tammy Duckworth, D-Illinois, lamented that Sanofi and AZ “seem to have vastly underestimated” the amount of Beyfortus—also known nirsevimab—needed to protect young kids during this disease season. The partners’ immunization, approved back in July, has quickly run into supply problems, with the CDC last month issuing an advisory for doctors to prioritize available Beyfortus 100-mg doses for infants at the highest risk of severe RSV. At the time, Sanofi attributed the shortfall to “higher than anticipated demand,” which has ...
- Source: drugdu
- 200
- November 22, 2023
CDC rushes extra doses of Sanofi, AZ’s Beyfortus to ease supply shortfall

In response to a supply squeeze for Sanofi and AstraZeneca’s respiratory syncytial virus (RSV) antibody Beyfortus, the U.S. Centers for Disease Control and Prevention (CDC) is fast-tracking tens of thousands of extra doses into circulation. More than 77,000 additional doses will be distributed “immediately” to physicians and hospitals through the CDC’s Vaccines for Children program and commercial routes, the agency said in a Thursday statement. Alongside the FDA, the CDC plans to maintain “close contact” with manufacturers to secure availability of extra supply through the end of this year and early 2024, the CDC added. The supply strain began last month despite Sanofi’s “aggressive” plan that was designed to “outperform past pediatric vaccine launches,” the company said at the time. The company said it was working with AstraZeneca to “explore a number of actions” to extend the manufacturing network. AZ handles manufacturing under the duo’s Beyfortus partnership. Sanofi previously noted ...
- Source: drugdu
- 139
- November 21, 2023
IO Biotech enrols 380 patients with advanced melanoma in phase 3 trial

The trial is evaluating an investigational cancer vaccine in combination with KeytrudaIO Biotech has announced that it has completed the enrolment of 380 patients in a phase 3 clinical trial of its investigational immune-modulating therapeutic cancer vaccine in advanced melanoma. The open-label, randomised clinical study being conducted in collaboration with Merck & Co – known as MSD outside the US and Canada – is comparing the candidate IO102-IO103 in combination with Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) versus Keytruda alone in patients with previously untreated, unresectable or metastatic melanoma. The cancer vaccine in combination with a PD-1 inhibitor has already demonstrated “approximately double the effect than would have been expected with PD-1 inhibitor monotherapy in this patient population,” said Mai-Britt Zocca, president and chief executive officer of IO Biotech, with results from a phase 1/2 study showing that 80% of patients achieved a response and 50% achieved a complete response. Furthermore, ...
- Source: drugdu
- 108
- November 17, 2023
Pfizer to Cut 500 Jobs at UK Site as Part of $3.5B Cost-Savings Campaign

Pictured: Sign at Pfizer’s headquarters in New York/iStock, JHVEPhoto Pfizer is planning to lay off around 500 of its staffers and terminate its Pharmaceutical Sciences Small Molecule functions at its facility in Sandwich, Kent in the U.K., according to several media reports on Tuesday.The business scale-back comes amid Pfizer’s sweeping cost-reduction plan announced last month, which will see the company generate $3.5 billion in savings through 2024. At the time, the company noted that the “cost realignment” initiative would include layoffs across its global operations, though the exact number of affected employees is still unknown. Local news outlet Kent Online reported that Tuesday’s layoffs were also part of a redundancy consultation program at the Sandwich site.In an emailed statement to Fierce Pharma, a Pfizer spokesperson clarified that the Sandwich facility would remain operational but “with a different size.” There are currently 940 employees at the U.K. site. It is the latest Pfizer location to ...
- Source: drugdu
- 127
- November 17, 2023
Pfizer’s cost-cutting campaign hits Sandwich site in UK, where 500 workers will lose jobs

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. Pfizer plans to cut approximately 500 roles and ax its Pharmaceutical Sciences Small Molecule (PSSM) capabilities at its site in Sandwich in Kent in the U.K., a company spokesperson confirmed over email. The spokesperson described the layoffs as a “one of the consequences” of Pfizer’s enterprisewide cost realignment program, which the drugmaker unveiled in mid-October. Under the current plan, the Sandwich site isn’t closing, and other functions will continue “with a different size,” the spokesperson added. Currently, around 940 people are employed at the facility. Local news outlet Kent Online earlier reported that Pfizer was proposing to discontinue all lab and manufacturing work at the Sandwich site.The site is the location where Pfizer scientists first discovered Viagra. During the pandemic, Pfizer invested 10 ...
- Source: drugdu
- 175
- November 16, 2023
Lilly Notches Second Cholesterol Win with RNA Silencer

By Tristan Manalac Data from an early-stage study showed that Eli Lilly’s investigational RNA silencing therapeutic lepodisiran can induce sharp and durable reductions in serum lipoprotein(a) levels, the company revealed in a read-out presented over the weekend at the 2023 Scientific Sessions of the American Heart Association. These findings come nearly three months after the Indianapolis-based pharma notched another Phase I victory, this time for its oral drug candidate muvalaplin, which strongly decreased lipoprotein(a) levels in healthy participants within 24 hours. Lipoprotein(a), also known as Lp(a), is a form of cholesterol that can cause plaques to form in arteries and block blood flow and is often tied to the risk of developing cardiovascular diseases. The first-in-human trial of lepodisiran enrolled 48 patients who were given ascending doses of the investigational therapy—from 4 mg up to 608 mg—or a placebo. At the highest dose level, lepodisiran was able to elicit a ...
- Source: drugdu
- 116
- November 15, 2023
Merck’s Keytruda combination receives CHMP recommendation for biliary tract cancer

Merck & Co – known as MSD outside the US and Canada – has announced that the European Medicines Agency’s human medicines committee has recommended its Keytruda (pembrolizumab) in combination with chemotherapy to treat biliary tract cancer (BTC). The Committee for Medicinal Products for Human Use (CHMP) has specifically recommended that the anti-PD-1 therapy be used alongside gemcitabine and cisplatin for the first-line treatment of adults with locally advanced unresectable or metastatic BTC. BTC is a group of rare and highly aggressive cancers in the liver, gallbladder and bile ducts. Approximately 211,000 people are diagnosed with the disease each year globally and about 70% of BTC patients are diagnosed at an advanced stage, at which point the prognosis is poor. The CHMP’s positive opinion was supported by results from the late-stage KEYNOTE-966 trial, in which the Keytruda/chemotherapy combination demonstrated a significant overall survival benefit in these patients versus chemotherapy alone. ...
- Source: drugdu
- 96
- November 15, 2023
Sanofi Issues Update on Shortages of Beyfortus for Respiratory Syncytial Virus

Pharmaceutical Executive Editorial Staff Due to a higher than anticipated demand, Sanofi is carefully managing distribution of 50 mg doses of Beyfortus in the private market to fulfill existing orders and provide equitable access to remaining doses for the vaccine that protects infants against respiratory syncytial virus. Sanofi has announced that a higher than expected demand for nirsevimab-alip (Beyfortus) 50 mg and 100 mg injection to protect infants against respiratory syncytial virus (RSV) has caused a change in the company’s distribution plan. Sanofi said it developed an aggressive supply plan to outperform prior launches of pediatric vaccines, but the demand exceeded the supply. Image credit: MargJohnsonVA | stock.adobe.com “We previously communicated that new orders for the 100 mg dose were no longer being accepted, as the demand exceeded the available supply for the season,” Sanofi said in a statement.1 “Currently, due to demand, we are carefully managing distribution of the ...
- Source: drugdu
- 98
- November 9, 2023
Moderna posts reported net loss of $3.6bn in Q3 earnings

Moderna has posted a reported net loss of $3.6bn in its Q3 earnings compared to a net income of $1bn during the same period last year, in line with the decreasing Covid-19-related revenues seen across the sector this year. For the quarter ended 1 October 2023, the company reported a diluted loss per share of $9.53. Revenues also saw a decline of 32% to $3.4bn from $5bn in the same quarter of the previous year. In its earnings release, Moderna attributed the drop in revenues to the expected decline in global revenue generated by the Covid-19 vaccine Spikevax. Spikevax revenues saw a 42% drop against the same quarter in 2022, from $3.1bn to $1.8bn. Still, the US market share to date of Spikevax grew to 45% from 36% in 2022, and Moderna anticipates 2024 revenues of approximately $4bn and return to growth in 2025. Part of this sales projection is ...
- Source: drugdu
- 146
- November 5, 2023
Moderna Posts Q3 Loss, Takes $1.3B in Write-Downs on COVID-19 Shots

By Tyler Patchen While Moderna’s total revenue for the third quarter beat Wall Street expectations, the vaccine maker on Thursday posted a loss as demand for its COVID-19 shots declined. Moderna announced that overall sales for the third quarter were $1.8 billion, down from $3.4 billion in the same period of 2022. Net product sales for Moderna were also down 44% from last year due to a “lower sales volume” but partially offset by a higher average selling price the company unveiled. In the third quarter, Moderna said it saw charges of $1.3 billion for “inventory writedowns,” which were related to “excess and obsolete COVID-19 products.” Investors were not pleased as Moderna’s stock price fell over 15% pre-market on Thursday. “Through this quarter, we demonstrated our ability to increase share in the U.S. market, and we now expect this year’s vaccination rate to be similar to last fall,” Moderna CEO ...
- Source: drugdu
- 163
- November 4, 2023

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