Bristol-Myers Squibb, Bayer team up on Opdivo-Stivarga combo in colorectal cancer

Fiercepharma | July 18, 2019

Bristol-Myers Squibb is out to expand the pool of colorectal cancer patients it can treat with Opdivo and its bringing in Bayer to help. The two companies, along with Bristol partner Ono Pharmaceutical, have joined forces in a clinical pact to test the immuno-oncology star alongside Bayers Stivarga in patients with microsatellite stable metastatic colorectal cancer, which represents about 95% of cases. The companies stayed tight-lipped on the collaboration’s terms, but they did note that they’ll be plotting an indication-seeking trial for the drug duo. Right now, Opdivo bears a green light to treat a sliver of the colorectal cancer patient population. Nearly two years ago, the FDA gave the treatment a go-ahead in those with microsatellite instability-high (MSI-H) metastatic colorectal cancer, a rare tumor type that makes sufferers less likely to respond to conventional chemo. In the broader colorectal cancer group, though, “I-O monotherapy treatment approaches have shown limited activity,” Bristol noted, “thus, the need for additional treatment options including combination approaches remains high.” Meanwhile, while Stivarga already has an OK for previously treated colorectal cancer that has spread to other parts of the body, it too could benefit from another indication in the disease. While its sales grew overall in 2018, in the U.S., sales declined thanks to “a highly competitive market environment.” Its competition in colorectal cancer includes Otsuka’s Lonsurf, another drug for previously treated patients whose cancer has spread.

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We believe that data-driven marketing shouldn’t be confusing. Every company should know what works for their campaigns in order to make more ROI-driven decisions. At Directive, we not only craft customized campaigns for your unique marketing objectives - we exceed those objectives and truly revolutionize your digital presence. We pride ourselves on the comprehensive and in-depth nature of the campaigns we build. From the outset - we prioritize transparent and accurate tracking to get the best picture of how campaigns are performing.

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Parallel's Surterra Wellness Stores to Introduce New Products Including Edibles in Florida

Prnewswire | August 31, 2020

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Corning Accelerates Delivery of Life-Saving Treatments and Critical Drugs with Expanded Pharmaceutical Glass Packaging Portfolio

Corning Incorporated | November 19, 2021

Corning Incorporated introduced Corning Velocity® Vials, specially engineered Type I borosilicate vials externally coated with the company’s proprietary technology, which are helping industry-leading drugmakers respond to the pandemic at speed. The increased efficiency and throughput enabled by Velocity Vials can drive faster manufacturing of COVID-19 vaccines, helping address industry supply chain challenges and meet global demand. Velocity Vials can deliver better economics, better quality, and a more environmentally sustainable design compared with traditional borosilicate packaging. Velocity Vials’ protective uniform coating can improve filling line efficiency by 20% to 50% while lowering pharmaceutical production costs and providing a streamlined regulatory process for post-market drugs. Compared with conventional vials, Velocity Vials can also reduce damage that leads to particles, breaks, and cracks. Catalent, Inc. – a global manufacturing partner to leading drugmakers – supports many of the highest profile COVID-19 vaccine programs and is on track to deliver more than 1 billion doses in 2021. The company recently implemented Velocity Vials in some of its fill-finish lines in Bloomington, Indiana. “Ensuring consistent production, high quality, and less downtime is essential as we work to keep pharmaceutical supply chains moving, and to this extent, Corning’s Velocity Vials have already shown very promising results. Corning’s Velocity Vials demonstrated a significant improvement in efficiency when compared with traditional borosilicate vials on our fill-finish lines.” Denis Johnson, vice president and general manager of Catalent’s premiere drug product manufacturing facility in Bloomington Velocity Vials join Corning Valor® Glass vials and pharmaceutical glass tubing as the company’s newest innovation as Corning builds a comprehensive, end-to-end pharmaceutical packaging portfolio. Corning’s products have enabled the delivery of more than 3 billion doses of COVID-19 vaccines. Valor Glass, introduced in 2017, is a revolutionary aluminosilicate glass vial that continues to support multiple COVID-19 vaccines, playing a significant role in vaccinating patients across the globe. Domestically, Corning continues building on its agreements with the U.S. government to support the accelerated mass vaccination effort critical to ending the pandemic. With the invention of Velocity Vials, the company extends its longstanding leadership role in the life sciences industry and broadens the reach of Corning’s unique capabilities, significantly expanding its addressable market while strengthening the supply chain for the future. Adding to the strong position in the industry, Corning’s new high-volume pharmaceutical vial manufacturing facility in Durham, North Carolina, is now operational. The facility will allow the company to produce up to 500 million glass vials per year to improve the domestic supply chain and deliver vital COVID-19 vaccines to the U.S. and abroad. “Our packaging portfolio and new capacity allow us to expand the vital role we play in supporting critical health care demand globally – both today and tomorrow,” said Brendan Mosher, vice president and general manager, Corning Pharmaceutical Technologies. “We see a future of pharmaceutical manufacturing that has better quality, is more efficient, more sustainable, and has increased capacity for life-saving drugs. Corning now has two leading vial products – Valor Glass and Velocity Vials – giving our customers two innovative technologies to choose from for their different use cases.” Velocity Vials are the latest example of how Corning is driving transformation across its markets through its leadership in glass and ceramic science and optical physics, as well as through its proprietary manufacturing platforms. For more information about Velocity Vials, visit here. Caution Concerning Forward-Looking Statements The statements contained in this release that are not historical facts or information and contain words such as “will,” “believe,” “anticipate,” “expect,” “intend,” “plan,” “seek,” “see,” “would,” and “target” and similar expressions are forward-looking statements. These forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include estimates and assumptions related to economic, competitive and legislative developments. Such statements relate to future events that by their nature address matters that are, to different degrees, uncertain. These estimates are subject to change and uncertainty which are, in many instances, beyond our control. There can be no assurance that future developments will be in accordance with management’s expectations. Actual results could differ materially from those expected by us, depending on the outcome of various factors. We do not undertake to update forward-looking statements. Although the Company believes that these forward-looking statements are based upon reasonable assumptions regarding, among other things, current estimates and forecasts, general economic conditions, its knowledge of its business, and key performance indicators that impact the Company, actual results could differ materially. The Company does not undertake to update forward-looking statements. Some of the risks, uncertainties and other factors that could cause actual results to differ materially from those expressed in or implied by the forward-looking statements include, but are not limited to: the duration and severity of the COVID-19 pandemic, and its impact across our businesses on demand, operations and our global supply chains; the effects of acquisitions, dispositions and other similar transactions; global business, financial, economic and political conditions; tariffs and import duties; currency fluctuations between the U.S. dollar and other currencies, primarily the Japanese yen, new Taiwan dollar, euro, Chinese yuan and South Korean won; product demand and industry capacity; competitive products and pricing; availability and costs of critical components and materials; new product development and commercialization; order activity and demand from major customers; the amount and timing of our cash flows and earnings and other conditions, which may affect our ability to pay our quarterly dividend at the planned level or to repurchase shares at planned levels; possible disruption in commercial activities due to terrorist activity, cyber-attack, armed conflict, political or financial instability, natural disasters, or major health concerns; loss of intellectual property due to theft, cyber-attack, or disruption to our information technology infrastructure; unanticipated disruption to our supply chain, equipment, facilities, IT systems or operations; effect of regulatory and legal developments; ability to pace capital spending to anticipated levels of customer demand; our ability to increase margins through implementation of operational changes, pricing actions and cost reduction measures; rate of technology change; ability to enforce patents and protect intellectual property and trade secrets; adverse litigation; product and components performance issues; retention of key personnel; customer ability, to maintain profitable operations and obtain financing to fund ongoing operations and manufacturing expansions and pay receivables when due; loss of significant customers; changes in tax laws and regulations; the impacts of audits by taxing authorities; the potential impact of legislation, government regulations, and other government action and investigations; and other risks detailed in Corning’s SEC filings. For a complete listing of risks and other factors, please reference the risk factors and forward-looking statements described in our annual reports on Form 10-K and quarterly reports on Form 10-Q. Web Disclosure In accordance with guidance provided by the SEC regarding the use of company websites and social media channels to disclose material information, Corning Incorporated (“Corning”) wishes to notify investors, media, to publish important information about the company, including information that may be deemed material to investors, or supplemental to information contained in this or other press releases. The list of websites and social media channels that the company uses may be updated on Corning’s media and website from time to time. Corning encourages investors, media, and other interested parties to review the information Corning may publish through its website and social media channels as described above, in addition to the company’s SEC filings, press releases, conference calls, and webcasts. About Corning Incorporated Corning is one of the world's leading innovators in materials science, with a 170-year track record of life-changing inventions. Corning applies its unparalleled expertise in glass science, ceramic science, and optical physics along with its deep manufacturing and engineering capabilities to develop category-defining products that transform industries and enhance people's lives. Corning succeeds through sustained investment in RD&E, a unique combination of material and process innovation, and deep, trust-based relationships with customers who are global leaders in their industries. Corning's capabilities are versatile and synergistic, which allows the company to evolve to meet changing market needs, while also helping our customers capture new opportunities in dynamic industries. Today, Corning's markets include optical communications, mobile consumer electronics, display, automotive, and life sciences.

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Pfizer and BioNTech Announce Submission of Initial Data to U.S. FDA to Support Booster Dose of COVID-19 Vaccine

Pfizer | August 17, 2021

Pfizer Inc. and BioNTech SE today announced that they have submitted Phase 1 data to the U.S. Food and Drug Administration (FDA) to support the evaluation of a third, or booster, dose of the companies’ COVID-19 vaccine (BNT162b2) for future licensure. These data also will be submitted to the European Medicines Agency (EMA) and other regulatory authorities in the coming weeks. “The data we’ve seen to date suggest a third dose of our vaccine elicits antibody levels that significantly exceed those seen after the two-dose primary schedule. We are pleased to submit these data to the FDA as we continue working together to address the evolving challenges of this pandemic.” “Vaccination is our most effective means of preventing COVID-19 infection – especially severe disease and hospitalization – and its profound impact on protecting lives is indisputable. Still, with the continuing threat of the Delta variant and possible emergence of other variants in the future, we must remain vigilant against this highly contagious virus,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “The data we’ve seen to date suggest a third dose of our vaccine elicits antibody levels that significantly exceed those seen after the two-dose primary schedule. We are pleased to submit these data to the FDA as we continue working together to address the evolving challenges of this pandemic.” “We continuously strive to stay at least one step ahead of the virus. This is why we aim to expand access to our vaccine for people around the world and are working on various approaches as part of our comprehensive strategy to address the virus and its variants today as well as in the future,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “This initial data indicate that we may preserve and even exceed the high levels of protection against the wild-type virus and relevant variants using a third dose of our vaccine. A booster vaccine could help reduce infection and disease rates in people who have previously been vaccinated and better control the spread of virus variants during the coming season.” Pfizer and BioNTech have submitted Phase 1 data – part of their Phase 1/2/3 clinical trial program – evaluating the safety, tolerability, and immunogenicity of a third dose of the COVID-19 vaccine in U.S. adult participants from the Phase 1 trial of the two-dose series. Participants received a 30-µg booster dose of BNT162b2 8 to 9 months after receiving the second dose. Results from this participant group show that the third dose elicited significantly higher neutralizing antibodies against the initial SARS-CoV-2 virus (wild type) compared to the levels observed after the two-dose primary series, as well as against the Beta variant and the highly infectious Delta variant. Phase 3 results evaluating the third dose are expected shortly and will be submitted to the FDA, the EMA and other regulatory authorities worldwide. In the U.S., Pfizer and BioNTech plan to seek licensure of the third dose via a supplemental Biologics License Application (BLA) in individuals 16 years of age and older, pending FDA approval of the primary BLA submitted in May 2021. A third dose of the Pfizer-BioNTech vaccine is not currently authorized for broad use in the U.S. However, under the current amended Emergency Use Authorization, a third dose was authorized on August 12 for administration to individuals at least 12 years of age who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. This authorization is based on information from an independent report evaluating safety and effectiveness of a third dose in people who received solid organ transplants. The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalent in the United States (jointly with Pfizer), Canada and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are ongoing or planned. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for use in individuals 12 years of age and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. AUTHORIZED USE IN THE U.S.: The Pfizer-BioNTech COVID19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older. IMPORTANT SAFETY INFORMATION Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (eg, anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines Reports of adverse events following use of the Pfizer-BioNTech COVID-19 Vaccine under EUA suggest increased risks of myocarditis and pericarditis, particularly following the second dose. The decision to administer the Pfizer-BioNTech COVID-19 Vaccine to an individual with a history of myocarditis or pericarditis should take into account the individual’s clinical circumstances Syncope (fainting) may occur in association with administration of injectable vaccines, in particular in adolescents. Procedures should be in place to avoid injury from fainting Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients In clinical studies, adverse reactions in participants 16 years of age and older included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%) In a clinical study, adverse reactions in adolescents 12 through 15 years of age included pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever (24.3%), joint pain (20.2%), injection site swelling (9.2%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%) Following administration of the Pfizer-BioNTech COVID-19 Vaccine, the following have been reported outside of clinical trials: severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions, diarrhea, vomiting, and pain in extremity (arm). myocarditis and pericarditis Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion There are no data available on the interchangeability of the Pfizer-BioNTech COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Pfizer-BioNTech COVID-19 Vaccine should receive a second dose of Pfizer-BioNTech COVID-19 Vaccine to complete the vaccination series Vaccination providers should review the Fact Sheet for Information to Provide to Vaccine Recipients/Caregivers and Mandatory Requirements for Pfizer-BioNTech COVID-19 Vaccine Administration Under Emergency Use Authorization. About Pfizer: At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us.

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