Mayne Pharma Announces FDA Filing Acceptance of New Drug Application for E4/DRSP in the US

Mayne Pharma, Mithra | June 24, 2020

Mayne Pharma Announces FDA Filing Acceptance of New Drug Application for E4/DRSP in the US
Mayne Pharma Group Limited (ASX: MYX) is pleased to announce the New Drug Application (NDA) for E4/DRSP to prevent pregnancy has been accepted for review by the US Food and Drug Administration (FDA). The FDA is expected to complete its review in the first half of calendar 2021.

Developed by Mithra Pharmaceuticals SA (Mithra), E4/DRSP is a novel combined oral contraceptive pill containing 15 mg estetrol (E4) and 3 mg drospirenone (DRSP). E4 is a naturally occurring estrogen that is produced by the human foetal liver during pregnancy. Following more than 20 years of research and development, Mayne Pharma's development and manufacturing partner, Mithra, can synthesise E4 at scale through a complex plant-based production process.

Spotlight

Sometimes, even your kitchen needs some myths busted. There are many things that we do everyday that have no more grounding other than habit, old wives' tales and misread or misremembered articles on the Internet. Who knows what kind of culinary shenanigans you get up to when you don't really know why you're doing what.

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BUSINESS INSIGHTS

TriMas Announces Two New Acquisitions

TriMas | December 14, 2021

TriMas announced that it has recently signed agreements to acquire Omega Plastics to be added to TriMas Packaging, and TFI Aerospace to be added to TriMas Aerospace. Omega, located in Clinton Township, Michigan, specializes in manufacturing custom components and devices for drug delivery, diagnostic and orthopedic medical applications, as well as components for industrial applications. Omega leverages its advanced in-house tool making capabilities, ISO13485-certified injection molding facility and ISO Class 8 clean room to provide its customers a faster product development cycle, from prototype development, testing and validation, to short and medium run production and assembly. Omega is an approved vendor to several leading medical device companies, with a long track record of unparalleled service and quality. Omega currently operates as a private, family-owned company, and is expected to generate approximately $18 million in revenue in fiscal year 2021. “We are excited to announce the agreement between TriMas and Omega. We look forward to expanding Omega’s production capacity to benefit its customers’ longer-term needs, while also leveraging Omega’s advanced tool making capabilities to add rapid prototyping to enhance TriMas Packaging’s speed-to-market advantage on innovation and new product designs. The addition of Omega further expands our Pharmaceutical & Nutraceutical product offerings into additional medical applications, which we believe is an attractive market for long-term growth.” Thomas Amato, President and Chief Executive Officer of TriMas Located near Toronto, Canada, TFI is a leading manufacturer and supplier of specialty fasteners used in a variety of applications, predominantly for the aerospace end market. TFI currently operates as a private, family-owned company, and is expected to generate approximately $6 million in revenue in fiscal year 2021. “In addition to expanding TriMas Packaging through the acquisition of Omega, we are also pleased to announce the acquisition of TFI,” Amato continued. “This acquisition will further expand TriMas Aerospace’s fastener product lines with the addition of complimentary niche products that have an exciting growth trajectory resulting from TFI’s new program wins and the overall aerospace market recovery. We anticipate TFI’s customers will benefit from the added innovation and manufacturing depth offered by TriMas Aerospace, while TriMas Aerospace’s customers will enjoy additional product offerings.” Amato continued, “We continue to execute on our core strategy of augmenting our growth through bolt-on acquisitions by leveraging our strong cash generation. After closing these two acquisitions, we expect our net leverage ratio to remain below 2.0x, providing ample capacity to execute on additional bolt-on acquisitions while also returning capital to shareholders through dividends and share buybacks.” TriMas expects to close on Omega by the end of the year, and closed on TFI simultaneously with signing. “We look forward to welcoming both Omega and TFI to the TriMas family of businesses,” concluded Amato. About TriMas TriMas is a global manufacturer and provider of products for customers primarily in the consumer products, aerospace and industrial markets, with approximately 3,300 dedicated employees in 11 countries. We provide customers with a wide range of innovative and quality product solutions through our market-leading businesses. Our TriMas family of businesses has strong brand names in the markets served, and operates under a common set of values and strategic priorities under the TriMas Business Model. TriMas is publicly traded on the NASDAQ under the ticker symbol “TRS,” and is headquartered in Bloomfield Hills, Michigan.

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PHARMACY MARKET

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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PHARMACY MARKET

Lilly Collaborates with Samsung to boost COVID-19 antibody manufacturing amid supply concerns

Lilly | November 18, 2020

Seven days after Eli Lilly won a FDA crisis approval for its COVID-19 counter acting agent, worries over restricted supplies are as of now springing up, and the organization is getting an accomplished assembling accomplice to help with the worldwide scale-up. Under a drawn out arrangement with Samsung Biologics, the organizations are set to "incredibly quicken the worldwide gracefully" for Lilly's COVID-19 antibodies, Samsung Biologics said in a delivery. Lilly would like to make up to 1 million dosages this year and a lot more in 2021, Reuters reports. The accomplices entered an underlying assembling association back in May, and, from that point forward, Samsung created a first clump of dynamic drug fixing in spite of struggling getting crude materials. The organizations took care of the tech move in under a quarter of a year, a consequence of routine collaborations between specialists at both medication creators, Samsung Biologics said. Lilly's bamlanivimab scored a FDA crisis use approval a week ago in gentle to-direct COVID-19 patients who are at a high danger of advancing to extreme illness. The FDA said the medication isn't approved in hospitalized patients, and Lilly is instructing imbuement inside 10 days concerning manifestation beginning. Before the crisis gesture, the organization entered a flexibly manage the U.S. government for 300,000 dosages at $1,250 per portion. All things considered, the stock could last only multi week dependent on current disease patterns, Reuters reports. While the arrangement incorporates a possibility for additional portions, specialists told the news administration they expect the medications will turn into a business drug sooner or later.

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Spotlight

Sometimes, even your kitchen needs some myths busted. There are many things that we do everyday that have no more grounding other than habit, old wives' tales and misread or misremembered articles on the Internet. Who knows what kind of culinary shenanigans you get up to when you don't really know why you're doing what.