PHARMACY MARKET

Sanofi's hopes for rare blood disease candidate sutimlimab on hold after FDA blasts 3rd-party manufacturer

Sanofi | November 17, 2020

When a new drug goes in front of the FDA for consideration, a lot of moving pieces must be in place for a successful review—manufacturing standards included. That didn't happen for Sanofi, which is pressing pause on a rare disease candidate after the FDA found issues at a contract manufacturer's plant.

The FDA blasted a third-party manufacturer of Sanofi's rare blood disease drug sutimlimab in a complete response letter, citing "certain deficiencies" at the contractor's site, the French drugmaker said Friday.

A Sanofi spokeswoman declined to specify who the manufacturer cited in the FDA's letter was or what the nature of the deficiencies were.

With its application on hold, Sanofi said it would work with its manufacturer and the FDA to resolve the issues in a "timely manner." The drugmaker didn't say how quickly it expected to turn around a new application.

The untimely feedback from the FDA dims C1 inhibitor sutimlimab's chances in cold agglutinin disease (CAD), a rare blood disease characterized by anemia, fatigue and other symptoms.

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Spotlight

There’s a good chance your diet leaves you nutritionally deficient. You may take (or may be thinking about taking) a supplement to make up the deficiency. Dietary supplements are not regulated the same way drugs are regulated, so it’s important to know what you’ll be buying before you head to the store. USP Verified Dietary Supplements are rigorously tested and audited using the four P’s of quality: Positive Identity, Potency, Purity, and Performance. Explore this infographic to learn more, and visit Quality Supplements to find out what supplements are USP Verified.

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IDC: Pharmaceutical industry ups inventory levels as OTIF rates fall

Pharmaceutical | November 19, 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. 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RESEARCH

Pfizer/Biontech Weren't Alone: Moderna Covid-19 Vaccine Data Aimed in Ema Cyberattack

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It would appear that Pfizer and BioNTech's COVID-19 immunization was not the sole objective of a new cyberattack at the European Medicines Agency. Moderna said Monday that reports from its pre-accommodation conversations with EMA about its shot, mRNA-1273, were "unlawfully gotten to" by programmers, refering to a warning from the organization. The assailants didn't get individual data about preliminary members, Moderna said. The organization's EMA accommodation did exclude any information recognizing people in the examination. Now, no extra insights concerning the cyberattack, for example, the size of the penetrate or the character of any suspects—are accessible, and Moderna said it anticipates results from EMA's progressing examination. The disclosure came days after the EMA initially uncovered the cyberattack, and Pfizer and BioNTech's COVID-19 immunization applicant, BNT162b2, was the principal distinguished as an objective. EMA choices on the two immunizations are moving close. Medication commentators at the EMA's Committee for Medicinal Products for Human Use are booked to evaluate BNT162b2 on Dec. 29 and mRNA-1273 on Jan. 12. Moderna was recently focused by programmers looking for its COVID-19 examination, in a cyberattack supposedly upheld by the Chinese government. The U.S. Branch of Justice in July arraigned two Chinese nationals for running a 10-year hacking effort that most as of late rotated to focusing on organizations doing COVID research. Reuters later affirmed Moderna as the antibody producer referenced in the arraignment. China has denied any function in such practices. Other than Moderna and Pfizer/BioNTech, rival COVID immunization designers AstraZeneca, Johnson and Johnson and Novavax apparently have arrived in the line of sight of North Korean programmers. In those hacking endeavors, the assailants regularly conveyed noxious reports or connections by means of email under the appearance of occupation enrollment specialists, partners or different associates of the person in question, as indicated by individuals acquainted with the issue refered to by The Wall Street Journal. Country state programmers from Iran and Russia have likewise been blamed for attempting to take COVID-related data.

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