Medical Network January 4th In 2017, the FDA approved 46 new drugs, breaking the record of the most approved new drugs in the 66 years since 2015 (45). Together with the newly approved biologics, 2017 is a big year for the pharmaceutical industry, and the FirstWord website has analyzed the most important products that are worthy of attention.
1 Dupixent : The potential to be dug
Indication- specific dermatitis enterprise regenerative element / Sanofi
Industry experts believe that Dupixent will change the guidelines for the treatment of moderate to severe atopic dermatitis, which will gradually establish a therapeutic benchmark for future products (competitive products have emerged). Since being approved for the treatment of specific dermatitis in March 2017, analysts have tracked Dupixent's acceptance of the product by dermatologists in 2017 and analyzed other indications that Dupixent may add in the future.
In 2017, Regeneration and Sanofi released data on Phase III clinical studies of Dupixent's effective treatment for severe asthma. With more and more data, both companies believe that Dupixent is a “multi-functional product†that evokes the imagination of whether the product can achieve the commercial height of “Kingyaâ€.
2 Hemlibra : Reshaping the market landscape
Indications hemophilia A company Roche
Hemlibra is used to treat patients with hemophilia A who have developed antibodies to factor VIII. The bispecific antibody Hemlibra, which is used once a week, also shows a significant and clinically significant reduction in bleeding in patients with factor VIII antibody negative. . Roche seems likely to break the pattern of the two markets, especially the former (which reduced the bleeding rate by 87% compared to patients who did not receive preventive treatment), giving Shire and Novo Companies such as Novo Nordisk pose new competitive threats. Because Hemlibra is more effective and more convenient to use. Despite some adverse reactions , the market generally predicts that Hemlibra's sales will reach $2 billion by 2022.
3-4 Kymriah/Yescarta : Launching CAR-T "First Battle"
Indications acute lymphoblastic leukemia enterprise Novartis
Indications diffuse large B- cell lymphoma company Gilead
Novartis' Kymriah received FDA approval in August 2017, becoming the world's first CAR-T product for children and adolescents with previously treated acute lymphoblastic leukemia. When Novartis launched Kymriah, it promised that if the patient did not respond to the treatment after one month, they would not have to pay for it (price is $475,000). Critical period data showed that 83% of the 63 evaluable patients achieved complete remission within 3 months. Novartis is seeking approval for the drug for indications of diffuse large B-cell lymphoma (DLBCL).
If Kymriah is approved for treatment with DLBCL, it will compete with Yescarta, which was approved by the FDA in October 2017. Yescarta was developed by Kite Pharmaceuticals, which was acquired by Gilead for $11.9 billion. The clinical data of Kymriah and Yescarta look very similar and the efficacy is more and more durable, suggesting that other factors (such as adverse reactions and logistical support) may be critical in achieving commercial success and competitive posture. There are reports that the competition in the CAR-T market will be a long battle.
5 Luxturna : Pricing is widely watched
Indications retinal malnutrition company Spark
Luxturna became the first drug in the United States to correct genetic defects and is a treatment for hereditary retinal dystrophy.
As a one-time treatment, Luxturna's spending is closely watched. Spark plans to disclose its pricing strategy in early 2018, and analysts predict that Luxturna's price could be as high as $1 million. In some patients, the drug has been shown to stop disease progression and restore some functional vision, and those who respond to treatment generally show signs of improvement within a month of treatment.
6 Ocrevus : Strong performance at the beginning of the market
Indications multiple sclerosis enterprise Roche
Ocrevus was approved by the FDA in March 2017, with early sales growth and strong first-year revenues close to the “blockbuster†level. Compared to the major competitors in the US market, Ocrevus is on the market at a clear price discount, and Roche's pricing strategy is commendable.
Although the market's indications are relapsing-remitting and primary-progressive MS (the first approved indication), experts believe that Octovus can also be used for secondary advanced patients. Market participants predict that Ocrevus' sales will exceed $4 billion in 2022.
7 Ozempic : regarded as the future pillar of the company
Indications Diabetes Enterprise Novo Nordisk
Novo Nordisk has determined that Ozempic will be the most important product for its next five years or even longer. This weekly long-acting GLP-1 agonist will further strengthen Novo Nordisk's leadership in these drugs on a daily basis from Victoza. The company is currently out of the competitive threat posed by Eli Lilly's Trulicity.
The indication for diabetes may be just the beginning of Ozempic, and the phase III clinical study data for the oral dosage form of Novo Nordsomaglutide (which industry experts believe will be a true game rule changer) will be published in 2018, by then. Ozempic's large-scale clinical research project to treat obesity will also be launched.
8-9 Rydapt/Idhifa : Breakthrough in AML treatment
Indications acute myeloid leukemia enterprise Novartis
Indications Acute Myeloid Leukemia Enterprise New Base Medicine / Agios
2017 is a breakthrough year for the treatment of acute myeloid leukemia (AML). For decades, the mainstay of the treatment of this disease has been the use of cytarabine-based chemotherapy regimens and some indications for other cancer treatments.
In April 2017, Novartis' Rydapt was approved for the treatment of newly diagnosed AML patients with FLT3 gene mutations. In August, Cegene and Agios Idhifa were approved for the treatment of recurrent AML in patients with IDH2 mutations.
10 Shingrix : GSK performance growth momentum
Product Category Herpes Zoster Vaccine Enterprise GlaxoSmithKline
In addition to Shingrix, in recent months GlaxoSmithKline has also been awarded the triple compound Trelegy Elipta for the treatment of COPD. These two new products can be used to assess the short-term performance of CEO Emma Walmsley since he took over GSK.
Shareholders hope that GSK will revitalize the pharmaceutical business, but in the short term, only vaccines will bring performance growth to the company. According to Bernstein analysts, the US Immunization Practice Advisory Committee (ACIP) believes that Shinglix is ​​better than Merck & Co.'s Zostavax, which greatly enhances Shinglix's commercial positioning. Analysts expect Shiningrix's global sales to reach around $1.7 billion by 2022. GSK may still be able to do better, especially considering that management has been strengthened recently.
11 Tremfya : The strong challenge of the latecomers
Indications Psoriasis company Johnson & Johnson
Perhaps considering the competitive threat of two IL-17 inhibitors, Novartis's Cosentyx and Lilly's Taltz, Johnson & Johnson used a priority review ticket to accelerate the FDA's approval of Tremfya. Johnson & Johnson's Stelara has been widely loved by dermatologists, and Tremfya provides further selectivity because the latter is only targeted at the IL-23 receptor, not both IL-12 and IL-23, which means lower Toxicity.
In addition, key data shows that Tremfya is better than Stelara and AbbVie's Xiu Mei Le. Less dosing is another advantage of Tremfya, but the need to overcome is that doctors are used to using Stelara, and Cosentyx and Taltz have different mechanisms of action. Despite this, Tremfya still has the potential for “blockbuster†in this crowded market.
12 Zejula : Two PARP inhibitors "first"
Indications ovarian cancer company Tesaro
PARP inhibitors remain a hot topic in 2017, and Tesaro's Zejula set two industry benchmarks when it received FDA approval in March: the first PARP inhibitor that does not require biomarker detection when used, A PPAR inhibitor approved for maintenance therapy in ovarian cancer patients who respond to chemotherapy. There are many rumors about Tesaro being targeted for acquisitions, but there is no substantive news, and the competition for PARP inhibitors remains fierce.
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