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Munnybunny
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Re: Pfizer

Bericht door Munnybunny »

Pfizer and BioNTech to Potentially Supply the EU with 200 Million Doses of mRNA-based Vaccine Candidate Against SARS-CoV-2


September 09, 2020 06:15 ET | Source: BioNTech SE
multilang-release

The proposed agreement is intended to provide a supply of 200 million doses and an option to purchase additional 100 million doses, with deliveries starting by the end of 2020, subject to regulatory approval

The vaccine supply for the EU would be produced by BioNTech’s manufacturing sites in Germany and Pfizer’s manufacturing site in Belgium

Pfizer and BioNTech are on track to seek regulatory review of BNT162b2 as early as October 2020 and, if regulatory authorization or approval is obtained, currently plan to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021
NEW YORK and MAINZ, Germany, Sept. 09, 2020 (GLOBE NEWSWIRE) -- Pfizer (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that they had concluded exploratory talks with the European Commission for a proposed supply of 200 million doses of their investigational BNT162 mRNA-based vaccine candidate against SARS-CoV-2 to European Union (EU) Member States, with an option for further 100 million doses. Deliveries would be starting by the end of 2020, subject to clinical success and regulatory authorization. The companies will now enter into contract negotiations with the European Commission.

The proposed supply agreement with the European Commission would represent the largest initial order of vaccine doses for Pfizer and BioNTech to date. Vaccine doses for Europe would be produced in BioNTech’s German manufacturing sites, as well as in Pfizer’s manufacturing site in Belgium. If regulatory approval for the BNT162b2 vaccine candidate is received, the European Commission would lead the process for allocation of the vaccine doses among the 27 EU Member States.

“Pfizer and BioNTech’s anticipated agreement with the European Commission is an important step forward in our shared goal to have millions of doses of a vaccine against COVID-19 available for vulnerable populations before the end of the year. We would like to thank the European Commission for its commitment and confidence in our development efforts,” said Albert Bourla, Chairman and CEO, Pfizer. “We have activated our supply chain, most importantly our site in Belgium, and are starting to manufacture so that our vaccine would be available as soon as possible, if our clinical trials prove successful and regulatory approval is granted.”

“As a company founded in the heart of Europe, we are pleased to have concluded exploratory discussions with the European Commission, which would be our largest initial order to date. Our aim is to develop a safe and effective vaccine to contribute to bringing this pandemic to an end in Europe and across the world. Today’s decision is a further illustration of how collaboration and solidarity can help address a global health crisis as an international community,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech.

In addition to engagements with governments, Pfizer and BioNTech have provided an expression of interest for possible supply to the COVAX Facility, a mechanism established by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI) and World Health Organization (WHO) that, using a range of technology platforms, aims to provide governments, including those in the emerging markets, with early access to a large portfolio of COVID-19 candidate vaccines produced by multiple manufacturers across the world.





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Munnybunny
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Pfizer COVID-19 vaccine trial reports no major safety issues
A site for clinical trials for a COVID-19 vaccine in Hollywood, Florida | BLOOMBERG

Sep 16, 2020
Researchers monitoring Pfizer Inc.’s giant trial of an experimental COVID-19 vaccine have reported no safety problems even after more than 12,000 people received their second of two doses.

“So far there has been no safety signal reported,” said Mikael Dolsten, Pfizer’s chief scientific officer, in an online meeting with investors. The trial, now targeted at enrolling 44,000 people, has reached its initial goal of 30,000 subjects, Pfizer executives said. The drugmakers have expanded the trial to to allow inclusion of teenagers and people with certain medical conditions, like HIV.

The trial compares two shots of the vaccine Pfizer is co-developing with Germany’s BioNTech SE to two doses of a placebo. While the doctors and subjects in the trial don’t know who got the vaccine — a measure to avoid bias — a committee of outside experts that knows which people received the shot is reviewing safety data on a weekly basis, Pfizer executives said during the investor meeting.

“They would notify us if they had any safety concerns and have not done that to date,” Kathrin Jansen, Pfizer’s head of vaccine research, said during the meeting. The company’s own scientists are also looking for worrisome adverse events that haven’t appeared so far. Fatigue has been the most common side effect seen in the trial thus far, according to the Pfizer presentation.

Pfizer confirmed it expects to get conclusive data on the vaccine’s efficacy by the end of October. The board monitoring the trial will conduct its first review of the data for efficacy when a total of 32 coronavirus cases have been seen among participants, Pfizer executives said during the investor meeting.

The company promised to make all its safety and efficacy data publicly available should it seek emergency authorization for the vaccine.


“What we are doing in terms of releasing data is very unusual,” Chief Executive Officer Albert Bourla said on a call with the press, citing ongoing conversations with U.S. regulators and Congress. “It is a must to release this data.”

The safety of experimental shots has been a paramount concern since AstraZeneca PLC paused tests of the vaccine it is co-developing with the University of Oxford following an adverse event in a U.K. subject. AstraZeneca Chief Executive Officer Pascal Soriot has said that it isn’t clear whether the participant had a condition called transverse myelitis, a suspected diagnosis, and an independent safety board was reviewing whether the participant’s illness had been caused by the vaccine or was unrelated. AstraZeneca’s U.K. trial has resumed, but its big U.S. trial remains on hold.


If a preliminary analysis of Pfizer and BioNTech’s vaccine data shows it’s effective, the companies could approach the Food and Drug Administration seeking emergency authorization. Bourla said the timing of such an authorization remains unclear.

The trial is designed to continue gathering safety and efficacy data even if an authorization was granted, Pfizer’s Jansen said on the press call. An emergency authorization would likely be for a very small subset of the population, and most people wouldn’t have access to the vaccine outside of the trial. That would allow the companies to continue gathering detailed results in different groups, she said.


Should Pfizer receive an emergency authorization, its top executives have given assurance that distribution will kick off immediately. The New York-based company has sufficient freezers and thermal shippers to be able to preserve the shot, which contains messenger RNA, a type of molecule that typically requires ultra-low temperatures for long-term storage.

Angela Hwang, Pfizer’s president of biopharmaceuticals, said that there are currently three options for distribution of its vaccine: With Pfizer’s freezers, vaccine providers can extend the shelf-life of the shot by six months; with thermal shippers and dry ice, they can keep the vaccine for 15 days; and with a typical refrigerator, the vaccine can last for five days. These different options “provide a wide range of flexibility,” Hwang said.


But Pfizer’s researchers are already looking for ways to create an improved version of the vaccine that would allow for storage at higher temperatures and for longer periods, which would ease distribution. The company is also exploring a new formulation that could be implemented in a single dose.
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Re: Pfizer

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Trump says Pfizer taking 'tremendous financial risk' in coronavirus vaccine development
President states drug company is 'spending billions of dollars' on vaccine

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Former CKE Restaurants CEO Andy Puzder on the future of small business amid protests, the payroll deferral tax and the stimulus stalemate.
President Trump on Wednesday said Pfizer was taking a "tremendous financial risk" in developing a coronavirus vaccine but that the pharmaceutical giant is confident in the results.



Pfizer CEO Albert Bourla has said the company could possibly know by October whether its potential vaccine to combat COVID-19 is effective.

"They're taking a tremendous risk and they're spending billions of dollars on actually making this vaccine," Trump told reporters at a White House briefing, "They're at this stage where they're actually making it because they feel very confident as to the results."

He said the company would be announcing its findings "very soon."

Trump also disputed a timeline on a vaccine after Dr. Robert Redfield, the director of the U.S.Centers for Disease Control and Prevention, told Congress earlier in the day that it would be ready for the public, possibly by the third quarter of next year.

Trump said he believed Redfield was "confused."

"I think he made a mistake when he said that. It's just incorrect information," Trump said.

He said the first vaccine doses could be distributed immediately once they are ready. The development of a vaccine is part of "operation Warp Speed," the Trump administration's $1.95 billion deal with the Pfizer and the German firm, BioNTech.

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Re: Pfizer

Bericht door BioCocktail »

Quick comparison of PFE/BNTX, MRNA protocols:

• PFE/BNTX has four interim looks (at 32, 62, 92, and 120 events); MRNA has two interim looks (at 53 and 106 events).

• PFE/BNTX has the final analysis at 164 events; MRNA has the final analysis at 151 events.

• PFE/BNTX has futility tests at the first three interim looks; MRNA does not have any futility tests.

• The definition of an “event” is slightly different in the two protocols (but probably not different enough to matter from a practical standpoint).

PFE/BNTX protocol (see p.103):
https://t.co/w0TU1yVe7T?amp=1

MRNA protocol (see p.98):
(https://t.co/The04HDHmE?amp=1

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Re: Pfizer

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Trump suggests Pfizer could win U.S. COVID-19 vaccine approval, JNJ to come later

WASHINGTON (Reuters) - U.S. President Donald Trump on Monday suggested Pfizer Inc could secure the first U.S. approval of a COVID-19 vaccine in coming weeks, saying a contender by Johnson & Johnson could come later.

Asked which drugmaker could be approved, Trump told Fox News in an interview: "Pfizer's doing really well," adding "Johnson & Johnson ... they'll probably be a little later." He also cited efforts by Moderna Inc and AstraZeneca Plc.

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Re: Pfizer

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Nog maar eens eens PB, maar aandeel beweegt niet.

Vivet Therapeutics en Pfizer Inc. zijn een productieovereenkomst aangegaan voor Vivets experimentele gentherapie voor de ziekte van Wilson

September 23, 2020 02:00 AM Eastern Daylight Time
PARIJS en NEW YORK--( BUSINESS WIRE )--Vivet Therapeutics ('Vivet'), een particulier biotechbedrijf in gentherapie dat is gewijd aan de ontwikkeling van behandelingen voor erfelijke leverstoornissen met een grote onvervulde medische behoefte, en Pfizer Inc. (NYSE: PFE) hebben vandaag aangekondigd dat ze een productieovereenkomst zijn aangegaan. De overeenkomst behelst dat Pfizer klinische benodigdheden zal leveren voor een klinisch fase 1/2-onderzoek ter evaluatie van de propriëtaire experimentele gentherapie, VTX-801, voor de potentiële behandeling van de ziekte van Wilson, een zeldzame en mogelijk levensbedreigende leverstoornis. Het onderzoek gaat naar verwachting begin 2021 van start. De bepalingen van de overeenkomst zijn niet bekendgemaakt.

In maart 2019 kondigden de bedrijven aan dat Pfizer een minderheidsbelang in Vivet had verworven en een exclusiviteitsoptie had verkregen om alle uitstaande aandelen te verwerven. De bedrijven hebben ook bekendgemaakt dat ze gaan samenwerken aan de ontwikkeling van VTX-801, waarvoor volgens plan in 2020 een aanvraag voor een Investigational New Drug (IND) zal worden ingediend bij de Amerikaanse Food and Drug Administration (FDA).

“De productie van potentieel transformerende gentherapeutische technologieën is een ongelofelijk complexe onderneming en we hopen dat deze belangrijke mijlpaal onze relatie met Pfizer verder versterkt terwijl de ontwikkeling van VTX-801 op lange termijn wordt verzekerd,” aldus Jean-Philippe Combal, mede-oprichter en CEO van Vivet Therapeutics.

De klinische benodigdheden voor het fase 1/2-onderzoek naar VTX-801 worden geproduceerd in de faciliteit van Pfizer in Chapel Hill in North Carolina. De afgelopen jaren heeft Pfizer aanzienlijk geïnvesteerd in de gentherapeutische productiefaciliteiten van het bedrijf in North Carolina om haar productiecapaciteit van zowel klinische als commerciële hoeveelheden gentherapeutisce producten uit te breiden voor patiënten rond de wereld die leven met een zeldzame ziekte.

“We zijn trots op de aanzienlijke vooruitgang die we tot nu toe hebben geboekt in onze gentherapeutische productiecapaciteiten en deze mijlpaal in onze relatie met Vivet benadrukt het belang van onze strategische investeringen in end-to-end gentherapeutisch onderzoek en benodigdheden ter ondersteuning van de tijdige levering van deze belangrijke therapieën voor patiënten,” stelde Seng Cheng, Chief Scientific Officer, Rare Disease Research Unit, Pfizer.

Over Vivet Therapeutics

Vivet Therapeutics is een opkomend biotechnologiebedrijf dat nieuwe gentherapiebehandelingen ontwikkelt voor zeldzame, erfelijke stofwisselingsziekten.

Vivet bouwt aan een gediversifieerde pijplijn voor gentherapie op basis van nieuwe adeno-geassocieerde virus (AAV)-technologieën die zijn ontwikkeld door middel van partnerschappen met en exclusieve licenties van de Fundación para la Investigación Médica Aplicada (FIMA), een stichting zonder winstoogmerk aan de Centro de Investigación Medica Aplicada (CIMA), Universiteit van Navarra in Pamplona, Spanje.

Het hoofdprogramma van Vivet, VTX-801, is een nieuwe experimentele gentherapie voor de ziekte van Wilson dat van de Amerikaanse Food and Drug Administration (FDA) en de Europese

Commissie (EC) het statuut van weesgeneesmiddel heeft gekregen. Deze zeldzame genetische aandoening wordt veroorzaakt door mutaties in het gen dat voor het ATP7B-eiwit codeert, waardoor de lever en andere weefsels minder goed in staat zijn om het kopergehalte te reguleren, met ernstige leverschade, neurologische symptomen en mogelijk overlijden tot gevolg.

Vivets tweede gentherapieproduct, VTX-803 voor PFIC3, kreeg in mei 2020 in de VS en de EU het statuut van weesgeneesmiddel.

Vivet wordt ondersteund door internationale investeerders in de levenswetenschappen, zoals Novartis Venture Fund, Roche Venture Fund, HealthCap, Pfizer Inc., Columbus Venture Partners, Ysios Capital, Kurma Partners en Idinvest Partners.

Bezoek ons op www.vivet-therapeutics.com en volg ons op Twitter op @Vivet_tx en LinkedIn.

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Munnybunny
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Re: Pfizer

Bericht door Munnybunny »

De drukpers staat niet stil.

FDA Accepts Supplemental New Drug Application for Pfizer’s XALKORI® (crizotinib) for the Treatment of Pediatric ALK-positive Anaplastic Large Cell Lymphoma If approved, XALKORI would be the first biomarker-driven therapy for Pediatric ALK-positive Anaplastic Large Cell Lymphoma

September 23, 2020 07:00 AM Eastern Daylight Time
NEW YORK--( BUSINESS WIRE )--Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review to the Company’s supplemental New Drug Application(sNDA)for XALKORI® (crizotinib) for the treatment of pediatric patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive. XALKORI received Breakthrough Therapy designation (BTD) for the ALK-positive ALCL indication in May 2018 and if approved, would be the first biomarker-driven therapy for this type of pediatric lymphoma. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is January 2020.

“Despite high survival rates for children with ALK-positive anaplastic large cell lymphoma, many will relapse, requiring novel treatment approaches,” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. “Today’s FDA filing exemplifies Pfizer’s commitment to broadening the use of biomarker-driven therapies in areas with significant needs, such as rare, pediatric cancers. Given XALKORI’s proven efficacy in ALK-positive lung cancer and activity seen in clinical trials investigating relapsed or refractory ALK- and ROS-1 positive anaplastic large cell lymphoma, if approved, XALKORI could represent an important step toward improving outcomes for children with this type of cancer.”

Anaplastic large cell lymphoma is a rare type of non-Hodgkin lymphoma (NHL), divided into ALK-positive or ALK-negative disease. 1,2 Though the five-year survival rate for children with cancer in the U.S. is now the highest it’s ever been at 80%, children with cancer continue to face challenges in treating their disease, including rare tumor types, variations in medicine response and prolonged risk of side effects. 3

“Children with cancer and their families have been desperate for new and innovative medicines. We applaud Pfizer’s commitment to drug discovery and development to help address childhood cancers, and continue to work together on behalf of patients with these cancers,” said George Dahlman, Chief Executive Officer, Children’s Cancer Cause. “We look forward to potentially having a new biomarker-driven therapy for children with relapsed or refractory ALK-positive ALCL that may help improve these children’s lives.”

The FDA submission is supported by the results from Study ADVL0912 (NCT00939770) and Study A8081013 (NCT01121588). Study ADVL0912 is a Phase 1/2 study conducted in collaboration with the Children’s Oncology Group (COG), evaluating the maximum dose that is safe and tolerable, and assessing clinical activity in pediatric patients with relapsed or refractory solid tumors and ALCL. Pfizer provided funding and support to COG for this trial. Study A8081013 evaluated XALKORI in pediatric and adult patients with advanced malignancies known to be ALK-positive other than non-small cell lung cancer (NSCLC) and included patients with relapsed or refractory ALCL. These two studies showed compelling antitumor activity in pediatric and adult patients who received XALKORI. 4,5 Please visit clinicaltrials.gov for more information on these studies.

This FDA submission is in addition to the European Medicines Agency’s agreement on a Pediatric Investigational Plan (PIP) for XALKORI including the treatment of pediatric patients with relapsed or refractory systemic ALK-positive ALCL. This decision represents a step forward for potential regulatory submission for XALKORI in pediatric patients with relapsed or refractory ALK-positive ALCL in the European Union.

About XALKORI ® (crizotinib)

XALKORI is a tyrosine kinase inhibitor (TKI) indicated for the treatment of patients with metastatic NSCLC whose tumors are ALK-positive or ROS1-positive as detected by an FDA-approved test. XALKORI has received approval for patients with ALK-positive NSCLC in more than 90 countries worldwide including Australia, Canada, China, Japan, South Korea and the European Union. XALKORI is also approved for ROS1-positive NSCLC in more than 70 countries.

The full prescribing information for XALKORI can be found here .

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