Search Results for “Pfizer” – Page 30 – media

Novavax Posts Surprise Q2 Profit, Hinges Hopes on Updated COVID Shot

By Connor Lynch Pictured: Gloved hand holding syringe in front of Novavax sign, Courtesy of rafapress/Getty Images Embattled vaccine maker Novavax is back in the black—at least, for now. In its second-quarter financial update Tuesday, the Maryland-based biotech posted a surprise $58 million in net income compared to a net loss of $510 million in the same period last year. Novavax reported second-quarter sales of $424.4 million, a significant increase from the expected $239.2 million in the quarter and $185.9 million during the same period in 2022. The latest update saw the biotech trim its full-year revenue forecast, but it is still anticipating between $1.3 and $1.5 billion in sales and grants, down from the $1.4 billion to $1.6 billion guidance provided in May. The company also entered into a stock purchase agreement with SK Bioscience, with Novavax issuing 6.5 million shares at $13 each to the South Korean company ...
- Source: drugdu
- 249
- August 10, 2023
Merck’s Pneumococcal Shot Claims Back-to-Back Phase III Wins

By Tristan Manalac Pictured: Merck sign at its office in California/iStock, hapabapa Merck’s investigational pneumococcal vaccine V116 aced two Phase III trials, eliciting strong immune responses in both the Phase III STRIDE-3 and STRIDE-6 trials, the company announced Thursday. Without providing specific data, the drugmaker said that in STRIDE-3, V116 significantly outperformed the standard 20-valent pneumococcal conjugate vaccine at eliciting an immune response in adults who had not been immunized before. Meanwhile, STRIDE-6 showed that Merck’s investigational shot could prime immunity against all 21 targeted pneumococcal serotypes in adults aged 50 years and above who had been vaccinated at least a year prior. Both STRIDE-3 and STRIDE-6 also demonstrated that V116’s safety profile was comparable to the standard vaccine comparator used in these studies. “Despite the availability of current pneumococcal conjugate vaccines, many adults remain vulnerable to pneumococcal disease, especially those who are older,” Merck Chief Medical Officer Eliav Barr ...
- Source: drugdu
- 124
- August 1, 2023
Biogen Boosts Neuro Pipeline with $7.3B Reata Buy Amid Layoffs

Published: Jul 28, 2023 By Tristan Manalac Pictured: Biogen sign/The Boston Globe via Getty, John Tlumacki Biogen is dropping $7.3 billion in cash to acquire Texas-based Reata Pharmaceuticals aimed at bolstering its neurological and rare disease businesses, the companies announced Friday. Reata, whose shares soared 51% in premarket trading following the buyout news, recently won the FDA’s approval for Skyclarys (omaveloxolone), the first and so far only authorized treatment for Friedrich’s ataxia in the U.S. Reata is currently working on launching Skyclarys, which it will price at $370,000 per year. Under the terms of the agreement, Biogen will pay a per-share price of $172.50, which represents an approximately 58% premium to Reata’s closing price Friday. Biogen will make the payment in cash, supplemented by the issuance of term debt. The companies expect to close the deal in the fourth quarter of 2023, though it must first pass the heightened scrutiny ...
- Source: drugdu
- 98
- August 1, 2023
Octapharma Secures FDA Nod for Warfarin Reversal Agent Balfaxar

More than 2.4 million people in the United States use warfarin to keep their blood from clotting after a heart attack, stroke or other serious thromboembolic complication. But using a blood thinner carries risks of its own as patients become prone to bleeding, particularly during urgent surgery or other invasive procedures. To combat the risk, Swiss plasma specialist Octapharma has developed a treatment that rapidly restores the blood’s ability to coagulate. On Wednesday, the FDA signed off on the company’s Balfaxar (prothrombin complex concentrate, human-lans). Already marketed as Octaplex in Europe and Canada, Balfaxar is for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonists such as warfarin. Balfaxar, which is a lyophilized powder for reconstitution, is provided with sterile water for injection by way of a new transfer device called Nextaro. The drug earned approval based on a phase 3 trial that ...
- Source: drugdu
- 141
- July 28, 2023
GSK Tamps Down Short-Term Expectations for RSV Shot Arexvy, but Still Boosts 2023 Guidance

Expectations are sky high for GSK’s entry this fall into the new respiratory syncytial virus (RSV) vaccine market. The company forecasts peak sales of £3 billion ($3.9 billion) for its shot Arexvy, while Global Data sees the vaccine as the market leader through 2029. But with Arexvy set to launch in the United States later this year, GSK is tamping down the anticipation. On Wednesday, CEO Emma Walmsley said that Arexvy will not hit the ground running as quickly as GSK’s shingles shot Shingrix, which generated £784 million ($1.05 billion) in its first full year on the market (2018). “It won’t be the same rate of build as Shingrix was,” Walmsley said as GSK presented its second-quarter earnings (PDF). “But we do think it is a really key pillar.” The competitive landscape was more favorable for Shingrix to thrive early on, Walmely said. She also noted that the newly established market for ...
- Source: drugdu
- 116
- July 28, 2023
Astellas Strikes Another Deal to Expand in Cancer, Partnering With PeptiDream

Photo: Kiyoshi Ota/Bloomberg, via Getty Images Astellas Pharma is far from alone in viewing cancer as a major growth area, but the Japanese drugmaker has specifically identified a type of therapy called targeted protein degradation as one of the key areas for increasing revenue. It just struck its second deal in the past two months to help it execute on that strategy and perhaps stand apart from others pursuing the same type of drugs. Under a partnership announced Tuesday, Astellas will work with PeptiDream to discover new protein degraders using the technology of that company. Specific targets were not disclosed, but they will be selected by Astellas. The deal also grants Tokyo-based Astellas the option to select up to three additional targets for inclusion in the collaboration. Astellas will pay PeptiDream 3 billion yen (about $21 million) up front. PeptiDream, based in Kawasaki, Japan, is eligible to receive up to ...
- Source: drugdu
- 115
- July 27, 2023
Bavarian Nordic Drops Out of RSV Vaccine Race with Phase III Flop

Pictured: Respiratory syncytial virus vial and syringe/iStock, Manjurul Bavarian Nordic’s portfolio has taken a hit as the company announced Saturday its respiratory syncytial virus vaccine candidate did not meet all primary endpoints in a Phase III study in older adults. While the vaccine candidate showed 59% efficacy in preventing at least two pre-defined lower respiratory tract disease (LRTD) symptoms from RSV, that number dropped to below the co-primary endpoint for severe LRTD in patients 60 and older. With the miss, Bavarian Nordic is discontinuing its RSV program. The decision also terminates its partnership with Nuance Pharma and chance for the coupled milestone payments of 195 million Danish kroner for developing and launching in select Asian markets. Bavarian Nordic CEO Paul Chaplin said in the release that the outcome was “unexpected” and will impact short-term growth expectations. However, the company said there is no impact on the financial guidance ...
- Source: drugdu
- 119
- July 26, 2023
Bavarian Nordic Falls by RSV Vaccine Wayside After Phase III Failure

The respiratory syncytial virus (RSV) vaccine arena lost a competitor on Saturday 21 July after Danish company Bavarian Nordic shelved its programme following missed endpoints in a Phase III trial. The candidate, named MVA-BN RSV, failed to meet the co-primary endpoint of severe lower respiratory tract disease (LRTD) based on at least three pre-defined symptoms, only demonstrating a 42.9% efficacy. The vaccine did, however, have a 59% efficacy in preventing at least two pre-defined LRTD symptoms. The randomised, double-blind Phase III trial (NCT05238025) involved 20,000 older adults across centres in the US and Germany. As a result of the programme termination, Bavarian Nordic has also ended its partnership with Nuance Pharma, a Chinese pharma company brought in to develop and launch the vaccine for Asian markets. Although Bavarian Nordic’s president and CEO Paul Chaplin said in a statement that the blow would impact short-term growth, ...
- Source: drugdu
- 113
- July 26, 2023
SN Bioscience’s Nano-Cancer Therapy Wins Orphan Drug Designation

The US Food and Drug Administration (FDA) granted SN Bioscience an orphan drug designation for its small cell lung cancer (SCLC) drug SNB-101, a polymer nanoparticle drug. The South Korea-headquartered company has received approval to run Phase I clinical trials in the US and South Korea, per a 20 July press release. The US trial (NCT04640480) is with solid tumours for any type of cancer. The orphan drug designation programme is an FDA initiative to support the development of new treatments for rare diseases. The classification gives sponsors tax credits from clinical trials, exemption from user fees, and a potential seven years of market exclusivity after approval. SNB-101 is an intravenously or intratumorally administered drug that acts as a topoisomerase I inhibitor. The therapy causes DNA breaks, inhibiting DNA replication and shutting down the cell cycle to prevent tumour growth. The drug uses the active ...
- Source: drugdu
- 103
- July 25, 2023
GSK-Funded Report on Adult Vaccination Rates Finds Major Global Declines in Recent Years

While vaccines for COVID-19 have certainly enjoyed the spotlight in recent years, rates of uptake for other shots have sharply declined.That’s the finding of a new analysis funded by GSK in collaboration with the IQVIA Institute for Human Data Science and the Global Coalition on Aging (GCOA). All told, about 100 million fewer doses than anticipated of some adult vaccines, other than those targeting COVID-19, were administered between 2021 and 2022, the team found. To reach this number, the group weighed vaccine use in the last two years versus trends in global vaccine adoption from 2013 to 2020. In fact, just 16.2 doses of some vaccines were doled out globally per 100 adults in 2022. Meanwhile, COVID-19 vaccines saw overwhelming success with 132 doses delivered for every 100 adults in the same year, according to the report. “While significant strides in vaccine development have delivered vaccines to ...
- Source: drugdu
- 207
- July 21, 2023

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