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FDA Acceptance of Zevra’s Arimoclomol NDA Filing for Niemann-Pick Disease Type C (NPC) Results in XOMA Making a $1 Million Milestone Payment to…

Posted: January 14, 2024 at 2:35 am

FDA has acknowledged receipt of the resubmission and assigned a PDUFA target action date of June 21, 2024 FDA has acknowledged receipt of the resubmission and assigned a PDUFA target action date of June 21, 2024

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FDA Acceptance of Zevra’s Arimoclomol NDA Filing for Niemann-Pick Disease Type C (NPC) Results in XOMA Making a $1 Million Milestone Payment to...

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Voting Rights and Shares Capital of the Company

Posted: January 14, 2024 at 2:35 am

In accordance with Articles L.233-8 II of the French Commercial Code and 223-16 of the General Regulation of the French Financial Markets Authority (Autorité des Marchés Financiers)

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Voting Rights and Shares Capital of the Company

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Santhera Receives Approval for AGAMREE® (Vamorolone) as a Treatment for Duchenne Muscular Dystrophy in the United Kingdom

Posted: January 14, 2024 at 2:35 am

Pratteln, Switzerland, January 12, 2024 – Santhera Pharmaceuticals (SIX: SANN) announces that AGAMREE® (vamorolone) has been approved in the United Kingdom (UK) for the treatment of Duchenne muscular dystrophy (DMD) in patients 4 years of age and older, independent of the underlying mutation and ambulatory status. The UK’s MHRA, adopting the view of the European Medicines Agency (EMA), acknowledged clinically important safety benefits of AGAMREE with regards to maintaining normal bone metabolism, density and growth compared to standard of care corticosteroids, alongside similar efficacy [1].

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Santhera Receives Approval for AGAMREE® (Vamorolone) as a Treatment for Duchenne Muscular Dystrophy in the United Kingdom

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CytomX Therapeutics to Present at the B. Riley Securities Virtual Annual Oncology Conference

Posted: January 14, 2024 at 2:35 am

SOUTH SAN FRANCISCO, Calif., Jan. 12, 2024 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated, localized biologics, today announced that Sean McCarthy, D.Phil., president, chief executive officer, and chairman, will participate in a fireside chat at the B. Riley Securities Virtual Annual Oncology Investor Conference on Thursday, January 18, 2024 at 1:00 p.m. ET.

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TransCode Therapeutics Reports Further Restructuring to Reduce Expenses and Increased Focus on Planned Phase 1 Clinical Trial, Retirement of CEO

Posted: January 14, 2024 at 2:35 am

BOSTON, Jan. 12, 2024 (GLOBE NEWSWIRE) -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics, today reported further steps in its previously-announced restructuring. The restructuring is intended to further reduce expenditures and enable greater concentration of company resources on a planned Phase 1 clinical trial for its lead therapeutic candidate, TTX-MC138. The restructuring follows a strategic review of the company’s operations to identify areas in which it could delay or reduce expenditures, including a previously announced reduction in headcount.

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TransCode Therapeutics Reports Further Restructuring to Reduce Expenses and Increased Focus on Planned Phase 1 Clinical Trial, Retirement of CEO

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Bioventus Announces Inducement Equity to President and Chief Executive Officer Robert Claypoole

Posted: January 14, 2024 at 2:35 am

DURHAM, N.C., Jan. 12, 2024 (GLOBE NEWSWIRE) -- Bioventus Inc. (Nasdaq: BVS) (“Bioventus” or the “Company”), a global leader in innovations for active healing, announced today the issuance on January 11, 2024 of previously disclosed inducement equity awards to Robert (Rob) Claypoole in connection with this appointment as President and Chief Executive Officer, and Principle Executive Officer of the Company.

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Bioventus Announces Inducement Equity to President and Chief Executive Officer Robert Claypoole

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Medicenna Announces Appointment of New Auditor

Posted: January 14, 2024 at 2:35 am

TORONTO and HOUSTON, Jan. 12, 2024 (GLOBE NEWSWIRE) -- Medicenna Therapeutics Corp. (“Medicenna” or the “Company”) (TSX: MDNA, OTC: MDNAF), a clinical-stage immunotherapy company focused on the development of Superkines, today announced the appointment of MNP LLP (“MNP” or “Successor Auditor”) as auditor. The board of directors of the Company accepted the resignation of PricewaterhouseCooper LLP (the “Former Auditor”) and appointed MNP as the new auditor until the next annual general meeting of shareholders of the Company.

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Medicenna Announces Appointment of New Auditor

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MCH to open free diabetes clinic thanks to $500,000 received from the City of Odessa – NewsWest9.com

Posted: January 14, 2024 at 2:34 am

MCH to open free diabetes clinic thanks to $500,000 received from the City of Odessa  NewsWest9.com

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Overview of Integrative, Complementary, and Alternative Medicine

Posted: January 14, 2024 at 2:33 am

The effectiveness of alternative therapies is an important consideration.

Many CAM therapies have been studied and found to be ineffective or inconsistent. Some therapies have been shown to be effective for specific conditions. However, these therapies are often also used to treat other conditions and symptoms, even though scientific evidence is lacking for these uses, as is sometimes the case in conventional medicine. Some CAM therapies have not been tested in well-designed studies. However, a lack of evidence from well-designed studies is not proof that a therapy is ineffective.

Many CAM therapies are said to have been practiced for hundreds or thousands of years. They include acupuncture Acupuncture Acupuncture, a therapy within traditional Chinese medicine, is one of the most widely accepted CAM therapies in the Western world. Licensed practitioners do not necessarily have a medical degree... read more , meditation Meditation In meditation, a type of mind-body medicine, people regulate their attention or systematically focus on particular aspects of inner or outer experience. Meditation may involve sitting or resting... read more , yoga, therapeutic diets Diet Therapy Diet therapy, a biologically based practice, uses specialized dietary regimens (such as the macrobiotic, paleo, Mediterranean, and low-carbohydrate diets) to Treat or prevent a specific disease... read more , massage Massage Therapy In massage therapy (a manipulative and body-based practice), body tissues are manipulated to reduce pain, relieve muscle tension, and reduce stress. Massage therapy involves a variety of light-touch... read more , and botanical medicine (dietary supplements Overview of Dietary Supplements Dietary supplements are used by about 75% of Americans. They are the most common therapies included among integrative medicine and health (IMH) and complementary and alternative medicine (CAM)... read more ). Having a long history of use is sometimes used as support that CAM therapies are effective. However, there are limitations with this argument:

Being used for a long time is not scientifically equivalent to proven effect. Some therapies subsequently found to be ineffective or harmful were previously used for many years.

The length of time a therapy has been in use can be difficult to establish.

How a therapy was used in the past may differ from how it is used now, as may the therapy itself.

Thus, scientific evidence, using well-designed studies, is still preferred to determine whether a therapy is effective.

However, well-designed studies of CAM therapies can be difficult to do. Barriers to doing research on CAM therapies include the following:

Lack of support and financial resources for CAM among sources that fund medical researchers

Limited training and skill to perform scientific research among advocates of CAM

Looser regulations requiring proof that CAM products or therapies are effective before they are made publicly available compared with regulations governing conventional medicine treatments

Generally lower financial returns for companies studying CAM than for those doing medication or device research

Applying conventional research methods to study CAM may be difficult for many additional reasons, including

Separating the effects of a CAM therapy's active component from those of placebo is difficult. For example, practitioners of CAM therapies typically interact with people in a positive and supportive way that is known to make people feel better, regardless of what other therapies are used. This aspect of CAM can be viewed as a placebo effect.

CAM therapies and diagnoses may not be standardized. For example, different practitioners use different systems of acupuncture, and the contents and effects of natural product preparations vary widely.

However, despite these challenges, many well-designed studies of CAM therapies (such as acupuncture Acupuncture Acupuncture, a therapy within traditional Chinese medicine, is one of the most widely accepted CAM therapies in the Western world. Licensed practitioners do not necessarily have a medical degree... read more and homeopathy Homeopathy Homeopathy, which was developed in Germany in the late 1700s, is a medical system based on the principle that like cures like (thus the name homeo [Greek for like] and patho [Greek for disease]... read more ) have been done. For example, one acupuncture study used a well-designed placebo, making double blinding possible, by placing an opaque sheath against the person's skin at an acupuncture point. Some sheaths contained a needle that penetrated the skin (active treatment), and some did not (placebo). For CAM therapies to be considered effective, there should be evidence that they are more effective when compared to a placebo or a control.

Lack of funding for well-designed CAM studies is often mentioned as a reason that these studies are not done. However, CAM products are a multi-billion dollar business, suggesting that lack of profitability should not be a reason companies do not study these products. However, profitability overall is much larger for conventional medication development than for CAM products.

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Overview of Integrative, Complementary, and Alternative Medicine

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Menopausal Hormone Therapy | Johns Hopkins Medicine

Posted: January 6, 2024 at 2:40 am

When a woman's body no longer makes estrogen, hormone therapy may be an option. But, hormone therapy (HT), in which estrogen and progestin (a synthetic progesterone) are used in combination, has been controversial over the years.

To learn more about women's health, and specifically hormone therapy, theNational Institutes of Health (NIH) did a study called the Women's Health Initiative (WHI)beginning in 1991. The studyinvolved more than 161,000 generally healthy postmenopausal women.

The study was designed to test the effects of postmenopausal hormone therapy, diet modification, and calcium and vitamin D supplements on heart disease, fractures, and breast and colorectal cancer in women.

The study had 2 arms:

Women with a uterus were given progestin in combination with estrogen, which is known to prevent endometrial cancer. All women were randomly assigned to either the hormone medicine being studied or to placebo (inactive substance).Compared with placebo, the estrogen plus progestin treatmentresulted in:

Small increase inrisk of heart attack (in women younger than 60 when combined hormone therapy is started in perimenopause, it may reduce risk of heart attack)

Small increase inrisk of stroke

Small increase inrisk of blood clots

Small increase in risk of breast cancer

Reduced risk of colorectal cancer

Fewer fractures

No protection against mild cognitive impairment and increased risk of dementia (study included only women 65 and older)

Compared with the placebo, treatment with estrogen alone resulted in:

No difference in risk for heart attack

Increased risk of stroke

Increased risk of blood clots

Reduced risk of breast cancer

No difference in risk for colorectal cancer

Reduced risk of fracture

The WHI recommends that women follow the FDA advice on hormone (estrogen-alone or estrogen-plus-progestin) therapy. It says that hormone therapy should not be taken to prevent heart disease.

These products are approved therapies for relief from moderate to severe hot flashes and symptoms of vaginal dryness. Although hormone therapy may be effective in preventing fractures, it should only be considered for women at high risk of osteoporosis who cannot take other medicines. The FDA recommends that hormone therapy be used at the lowest doses for the shortest time needed to achieve treatment goals. Postmenopausal women who use or are considering using hormone therapy should discuss the possible benefits and risks to them with their healthcare providers.

The National Heart, Lung, and Blood Institute offers the following suggestions for women who are deciding whether or not to use hormone therapy:

The most important thing a woman can do in deciding to continue hormone therapy is discuss the current research with her healthcare provider.

Women need to be aware that taking a combined progesterone and estrogen regimen or estrogen alone is no longer recommended to prevent heart disease. A woman should discuss other ways of protecting the heart with her healthcare provider.

Women should discuss with their healthcare providers the value of taking combined progesterone and estrogen therapy or estrogen to prevent osteoporosis. There may be other treatments based on a woman's health profile.

Always consult your healthcare provider for more information.

Asa woman approaches menopause, the production of estrogen and progesterone fluctuates and then decreases significantly. Symptoms such as hot flashes often result from the changing hormone levels. After a woman's last menstrual period, when her ovaries make much less estrogen and progesterone, some symptoms of menopause might disappear, but others may continue.

To help relieve these symptoms, some women use hormones. This is called menopausal hormone therapy (MHT). This approach used to be called hormone replacement therapy or HRT. MHT describes several different hormone combinations available in a variety of forms and doses.

Hormone therapycan be given in a variety of methods, including the following:

For women who are appropriate candidates, this type of therapy can often be customized to provide the most benefits with the least side effects. It is important for women to talk with their healthcare providers about any discomfort or menstrual symptoms experienced with hormone treatment, as treatment approaches and dosages can be adjusted.

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